MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT
FDA 510(k) clearance K081516 · decided 2008-08-26
Clearance details
- K-number
- K081516
- Device name
- MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT
- Applicant
- Medsource International, LLC
- Decision
- Substantially Equivalent
- Date received
- 2008-05-30
- Decision date
- 2008-08-26
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- CBP
- Device class
- 2
- Regulation number
- 868.5870
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mound, MN, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.