EXHALED HYDROGEN MONITOR
FDA 510(k) clearance K820652 · decided 1982-04-01
Clearance details
- K-number
- K820652
- Device name
- EXHALED HYDROGEN MONITOR
- Applicant
- Keymed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-03-09
- Decision date
- 1982-04-01
- Days to decision
- 23 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- 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.