HYPERLITE
FDA 510(k) clearance K905168 · decided 1991-07-22
Clearance details
- K-number
- K905168
- Device name
- HYPERLITE
- Applicant
- S.O.S. , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1990-11-16
- Decision date
- 1991-07-22
- Days to decision
- 248 days
- Clearance type
- Traditional
- Product code
- CBF
- Device class
- 2
- Regulation number
- 868.5470
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- London Nw73js, England, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.