Periflux PF4001 Laser Doppler Flowmeter
FDA 510(k) K922368 · Perimed, Inc.
510(k) numberK922368
Submission
- Device name
- Periflux PF4001 Laser Doppler Flowmeter
- Applicant
- Perimed, Inc.
Piscataway, NJ, US - Received
- May 20, 1992
- Decision date
- February 3, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DPW – Flowmeter, Blood, Cardiovascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2100
- Specialty
- Cardiovascular
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Questions and answers
When was Periflux PF4001 Laser Doppler Flowmeter cleared by the FDA?
Periflux PF4001 Laser Doppler Flowmeter (K922368) received a 510(k) decision of Substantially Equivalent on February 3, 1993, 259 days after the submission was received.
What is the product code of K922368?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.