510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K980878Substantially Equivalent

Pulmotrack,model 1010

Karmel Medical Acoustic Technologies, Ltd., Tirat Hacarmel, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980878 is the FDA 510(k) clearance record for PULMOTRACK,MODEL 1010, a class II device, cleared for Karmel Medical Acoustic Technologies , Ltd. on under FDA product code BZM (Calculator, Pulmonary Function Interpretor (Diagnostic)). FDA records list one 510(k) clearance for Karmel Medical Acoustic Technologies , Ltd. As of , FDA records show no recalls naming K980878.

Clearance record

Decision date
Received
(294 days to decision)
Product code
BZM Calculator, Pulmonary Function Interpretor (Diagnostic)
Regulation
21 CFR 868.1900
Device class
Class II
Review panel
Anesthesiology
Applicant
Karmel Medical Acoustic Technologies , Ltd. 9 Ezel St., P.O. Box 389, Tirat Hacarmel, IL
510(k) summary
Summary
Third party review
No

Clearances, product code BZM

Trailing 12 months

FDA records hold no clearances under product code BZM in the trailing twelve months.

FDA records show no clearances under product code BZM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BZM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260