VEDLAR VENTILATOR (MODIFICATION)
FDA 510(k) clearance K854026 · decided 1985-10-23
Clearance details
- K-number
- K854026
- Device name
- VEDLAR VENTILATOR (MODIFICATION)
- Applicant
- Hamilton Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-08-26
- Decision date
- 1985-10-23
- Days to decision
- 58 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Reno, NV, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.