DISPOSABLE SPO2 SENSOR M1134A
FDA 510(k) clearance K091572 · decided 2009-09-22
Clearance details
- K-number
- K091572
- Device name
- DISPOSABLE SPO2 SENSOR M1134A
- Applicant
- Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
- Decision
- Substantially Equivalent
- Date received
- 2009-06-02
- Decision date
- 2009-09-22
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- DQA
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Boeblingen, Baden-Wuerttemberg, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.