INSPIROMETER RESPIRATORY EXERCISER
FDA 510(k) clearance K770141 · decided 1977-02-01
Clearance details
- K-number
- K770141
- Device name
- INSPIROMETER RESPIRATORY EXERCISER
- Applicant
- Medi, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-01-24
- Decision date
- 1977-02-01
- Days to decision
- 8 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.