RE-VENT ARTERIAL BLOOD SAMPLER AND/OR BIOSAMPLER
FDA 510(k) clearance K882975 · decided 1989-01-25
Clearance details
- K-number
- K882975
- Device name
- RE-VENT ARTERIAL BLOOD SAMPLER AND/OR BIOSAMPLER
- Applicant
- Richmann Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1988-07-15
- Decision date
- 1989-01-25
- Days to decision
- 194 days
- Clearance type
- Traditional
- Product code
- FMF
- Device class
- 2
- Regulation number
- 880.5860
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Lake Park, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.