PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNIT— 510(k) K974285
Substantially EquivalentPerimed, Inc.
FDA 510(k) clearance K974285 for PERIFLUX SYSTEM 5000 MODULAR LASER DOPPLER SYSTEM MAIN UNIT MODEL PF 5001, INCLUDING PF 5010 LDPM UNIT, Substantially Equivalent on 1998-05-28. Applicant: Perimed, Inc.. Device class: 2.
Clearance details
- Applicant
- Perimed, Inc.
- Product code
- Product code DPW
- Device class
- Class 2
- Regulation
- 21 CFR 870.2100
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Smithtown, NY, US
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