MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP
FDA 510(k) clearance K894667 · decided 1989-10-19
Clearance details
- K-number
- K894667
- Device name
- MODELS PB950 AND PB960 DATALOOP AND SPIROLOOP
- Applicant
- Pneumedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-07-25
- Decision date
- 1989-10-19
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- BTY
- Device class
- 2
- Regulation number
- 868.1890
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Milford, CT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.