KNIGHTSTAR 335
FDA 510(k) clearance K973004 · decided 1998-07-16
Clearance details
- K-number
- K973004
- Device name
- KNIGHTSTAR 335
- Applicant
- Puritan Bennett Corp.
- Decision
- Substantially Equivalent
- Date received
- 1997-08-13
- Decision date
- 1998-07-16
- Days to decision
- 337 days
- Clearance type
- Traditional
- Product code
- MNT
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Lenexa, KS, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.