OXYGEN SATURATION METER MODEL NO. SM-1
FDA 510(k) clearance K802847 · decided 1980-12-16
Clearance details
- K-number
- K802847
- Device name
- OXYGEN SATURATION METER MODEL NO. SM-1
- Applicant
- Bentley Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-11-12
- Decision date
- 1980-12-16
- Days to decision
- 34 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.