STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964
FDA 510(k) clearance K990574 · decided 1999-05-24
Clearance details
- K-number
- K990574
- Device name
- STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964
- Applicant
- Respironics, Inc.
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Date received
- 1999-02-23
- Decision date
- 1999-05-24
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- MNT
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Murrysville, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.