FDA 510(k) K930748, SIGMA MP MULTIPLACE HYPERBARIC CHAMBER, by Perry Baromedical Services
FDA 510(k) K930748, SIGMA MP MULTIPLACE HYPERBARIC CHAMBER, by Perry Baromedical Services
| 510(k) Number | K930748 |
| Device Classification Name | Chamber, Hyperbaric |
| Device Name | SIGMA MP MULTIPLACE HYPERBARIC CHAMBER |
| Applicant | Perry Baromedical Services 7555 Garden Rd. Suite B Riviera Beach, FL 33404 |
| Regulation Number | 868.547 |
| Classification Product Code | CBF |
| Date Received | 02/12/1993 |
| Decision Date | 08/20/1993 |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | Anesthesiology |
| 510k Review Panel | Anesthesiology |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | No |
| Total Pages | 278 |
| Redacted Pages | 101 |
| Unredacted Pages | 177 |
Couldn't load pickup availability
PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.
View full details