MASTER SCREEN PNUEMO
FDA 510(k) clearance K933839 · decided 1994-03-07
Clearance details
- K-number
- K933839
- Device name
- MASTER SCREEN PNUEMO
- Applicant
- Erich Jaeger, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-08-05
- Decision date
- 1994-03-07
- Days to decision
- 214 days
- Clearance type
- Traditional
- Product code
- BTY
- Device class
- 2
- Regulation number
- 868.1890
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Rockford, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.