ANAESTHESIA RECORD KEEPER
FDA 510(k) clearance K923172 · decided 1994-08-09
Clearance details
- K-number
- K923172
- Device name
- ANAESTHESIA RECORD KEEPER
- Applicant
- Datex Division Instrumentarium Corp.
- Decision
- Substantially Equivalent
- Date received
- 1992-06-29
- Decision date
- 1994-08-09
- Days to decision
- 771 days
- Clearance type
- Traditional
- Product code
- BSZ
- Device class
- 2
- Regulation number
- 868.5160
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Helsinki, Finland, FI
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.