PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNIT
FDA 510(k) clearance K974285 · decided 1998-05-28
Clearance details
- K-number
- K974285
- Device name
- PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNIT
- Applicant
- Perimed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-11-14
- Decision date
- 1998-05-28
- Days to decision
- 195 days
- Clearance type
- Traditional
- Product code
- DPW
- Device class
- 2
- Regulation number
- 870.2100
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Smithtown, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.