MODEL LP-1000 VOLUME VENTILATOR
FDA 510(k) clearance K952880 · decided 1996-06-20
Clearance details
- K-number
- K952880
- Device name
- MODEL LP-1000 VOLUME VENTILATOR
- Applicant
- Aequitron Medical, Inc.
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Date received
- 1995-06-22
- Decision date
- 1996-06-20
- Days to decision
- 364 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.