PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132A
FDA 510(k) clearance K063783 · decided 2007-04-27
Clearance details
- K-number
- K063783
- Device name
- PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132A
- Applicant
- Philips Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-12-21
- Decision date
- 2007-04-27
- Days to decision
- 127 days
- Clearance type
- Special
- Product code
- DQA
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.