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510(k) K880550

BURROWS-KNUDSON AUTOMATED LUNG FUNCTION INTER. SYS by Medimicro Systems, Inc. — Product Code BZM

K880550 is an FDA 510(k) premarket notification submitted by Medimicro Systems, Inc. for the device "BURROWS-KNUDSON AUTOMATED LUNG FUNCTION INTER. SYS". The FDA issued a decision of Substantially Equivalent on July 25, 1988. The device falls under product code BZM (Calculator, Pulmonary Function Interpretor (Diagnostic)), a Class II device regulated under 21 CFR 868.1900.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 1988
Date Received
February 9, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Pulmonary Function Interpretor (Diagnostic)
Device Class
Class II
Regulation Number
868.1900
Review Panel
AN
Submission Type

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  • K980878 — PULMOTRACK,MODEL 1010 (December 28, 1998)
  • K974200 — ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM (July 21, 1998)
  • K955432 — CPX, CCM, CATH WITH 15% CO2 (July 1, 1996)
  • K923209 — MEDGRAPHICS EXERCISE CONSULT (March 11, 1993)
  • K911143 — PB100 DIAGNOSTIC SPIROMETER (November 29, 1991)
  • K896345 — EXERCISE EVALUATION SYSTEM 2010 (January 20, 1990)

FDA data resources