Modified Laserflo Blood Perfusion Monitor

FDA 510(k) K864259 · Tsi, Inc.

Substantially Equivalent

510(k) numberK864259

Submission

Device name
Modified Laserflo Blood Perfusion Monitor
Applicant
Tsi, Inc.
St. Paul, MN, US
Received
October 29, 1986
Decision date
February 20, 1987
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
K896515Laserflo Blood Perfusion Monitor, Model BPM2DPW · Traditional 02/13/1990SE
K875179Modified Laserflo Blood Perfusion Monitor, BPM403ADPW · Traditional 09/19/1988SE
K851057Laserflo Blood Perfusion Monitor 403DPW · Traditional 06/24/1985SE

Questions and answers

When was Modified Laserflo Blood Perfusion Monitor cleared by the FDA?

Modified Laserflo Blood Perfusion Monitor (K864259) received a 510(k) decision of Substantially Equivalent on February 20, 1987, 114 days after the submission was received.

What is the product code of K864259?

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