MANUAL RESUSCITATOR WITH ACE
FDA 510(k) clearance K982215 · decided 1998-09-18
Clearance details
- K-number
- K982215
- Device name
- MANUAL RESUSCITATOR WITH ACE
- Applicant
- Medical Marketing Concepts
- Decision
- Substantially Equivalent
- Date received
- 1998-06-23
- Decision date
- 1998-09-18
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- BTM
- Device class
- 2
- Regulation number
- 868.5915
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Crofton, MD, US
- Third-party review
- No
- Expedited review
- No
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