FDA 510(k) K183067, Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System, by Taiwan Aulisa Medical Devices Technologies, Inc.
FDA 510(k) K183067, Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System, by Taiwan Aulisa Medical Devices Technologies, Inc.
Device Classification Name: Oximeter
510(k) Number: K183067
Device Name: Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System
Applicant: Taiwan Aulisa Medical Devices Technologies, Inc.
Regulation Number: 870.27
Classification Product Code: DQA
Date Received: 2018-11-05
Decision Date: 2019-03-01
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
510k Review Panel: Anesthesiology
Total number of pages: 1,751
Fully redacted pages: 1,545
Content pages: 206
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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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