FDA 510(k) K945118, EXPIRATORY BREATHING EXERCISER, by Dhd Diemolding Healthcare Div.

FDA 510(k) K945118, EXPIRATORY BREATHING EXERCISER, by Dhd Diemolding Healthcare Div.

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Device Classification Name: Spirometer, Therapeutic (Incentive)
510(k) Number: K945118
Device Name: EXPIRATORY BREATHING EXERCISER
Applicant: Dhd Diemolding Healthcare Div.
Regulation Number: 868.5690
Classification Product Code: BWF
Date Received: 10/18/1994
Decision Date: 01/13/1995
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
510k Review Panel: Anesthesiology

Total number of pages: 144
Fully redacted pages: 63
Content pages: 81

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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.

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