INCENTIVE SPIROMETER
FDA 510(k) clearance K760762 · decided 1976-10-08
Clearance details
- K-number
- K760762
- Device name
- INCENTIVE SPIROMETER
- Applicant
- I-Spiron
- Decision
- Substantially Equivalent
- Date received
- 1976-10-04
- Decision date
- 1976-10-08
- Days to decision
- 4 days
- Clearance type
- Traditional
- Product code
- BWF
- Device class
- 2
- Regulation number
- 868.5690
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.