RENEAU UNIT
FDA 510(k) clearance K840841 · decided 1984-08-07
Clearance details
- K-number
- K840841
- Device name
- RENEAU UNIT
- Applicant
- Reneau, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-02-24
- Decision date
- 1984-08-07
- Days to decision
- 165 days
- Clearance type
- Traditional
- Product code
- CBF
- Device class
- 2
- Regulation number
- 868.5470
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.