MANUAL VENTILATION ACCESSORY
FDA 510(k) clearance K854036 · decided 1985-10-23
Clearance details
- K-number
- K854036
- Device name
- MANUAL VENTILATION ACCESSORY
- Applicant
- Siemens Elema AB
- Decision
- Substantially Equivalent
- Date received
- 1985-08-27
- Decision date
- 1985-10-23
- Days to decision
- 57 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Schaumburg, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.