L.A.P. SPIROMETER
FDA 510(k) clearance K864836 · decided 1987-03-06
Clearance details
- K-number
- K864836
- Device name
- L.A.P. SPIROMETER
- Applicant
- Timeter Instrument Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-12-09
- Decision date
- 1987-03-06
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- BTY
- Device class
- 2
- Regulation number
- 868.1890
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Lancaster, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.