Laserflo Blood Perfusion Monitor, Model BPM2

FDA 510(k) K896515 · Tsi, Inc.

Substantially Equivalent

510(k) numberK896515

Submission

Device name
Laserflo Blood Perfusion Monitor, Model BPM2
Applicant
Tsi, Inc.
Findley, MN, US
Received
November 15, 1989
Decision date
February 13, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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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More from Remington Medical, Inc.

510(k)DeviceDecision
K875179Modified Laserflo Blood Perfusion Monitor, BPM403ADPW · Traditional 09/19/1988SE
K864259Modified Laserflo Blood Perfusion MonitorDPW · Traditional 02/20/1987SE
K851057Laserflo Blood Perfusion Monitor 403DPW · Traditional 06/24/1985SE

Questions and answers

When was Laserflo Blood Perfusion Monitor, Model BPM2 cleared by the FDA?

Laserflo Blood Perfusion Monitor, Model BPM2 (K896515) received a 510(k) decision of Substantially Equivalent on February 13, 1990, 90 days after the submission was received.

What is the product code of K896515?

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