MAC/IV SEDATION KIT
FDA 510(k) clearance K935546 · decided 1994-06-13
Clearance details
- K-number
- K935546
- Device name
- MAC/IV SEDATION KIT
- Applicant
- Vital Signs, Inc.
- Decision
- Unknown
- Date received
- 1993-11-17
- Decision date
- 1994-06-13
- Days to decision
- 208 days
- Clearance type
- Traditional
- Product code
- BSZ
- Device class
- 2
- Regulation number
- 868.5160
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Totowa, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.