Pim 1.0 Laser Doppler Perfusion Imager

FDA 510(k) K920844 · Lisca Development AB

Substantially Equivalent

510(k) numberK920844

Submission

Device name
Pim 1.0 Laser Doppler Perfusion Imager
Applicant
Lisca Development AB
Linkoping, SE
Received
February 24, 1992
Decision date
July 21, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

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 Pim 1.0 Laser Doppler Perfusion Imager cleared by the FDA?

Pim 1.0 Laser Doppler Perfusion Imager (K920844) received a 510(k) decision of Substantially Equivalent on July 21, 1992, 148 days after the submission was received.

What is the product code of K920844?

The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.