LC STAR WITH NASAL ADAPTER
FDA 510(k) clearance K061381 · decided 2006-06-02
Clearance details
- K-number
- K061381
- Device name
- LC STAR WITH NASAL ADAPTER
- Applicant
- Pari Innovative Manufacturers, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-05-18
- Decision date
- 2006-06-02
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- CAF
- Device class
- 2
- Regulation number
- 868.5630
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Midlothian, VA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.