510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003287Substantially Equivalent

Model K7 Evaluation Device

Myotronics-Noromed, Inc., Tukwila WA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K003287 is the FDA 510(k) clearance record for MODEL K7 EVALUATION DEVICE, a class II device, cleared for Myotronics-Noromed, Inc. on under FDA product code KZM (Device, Muscle Monitoring). FDA records list 7 510(k) clearances for Myotronics-Noromed, Inc., from to . As of , FDA records show no recalls naming K003287.

Clearance record

Decision date
Received
(17 days to decision)
Product code
KZM Device, Muscle Monitoring
Regulation
21 CFR 890.1375
Device class
Class II
Review panel
Physical Medicine
Applicant
Myotronics-Noromed, Inc. 15425 53rd Ave. S., Tukwila WA
510(k) summary
Summary
Third party review
No

Clearances, product code KZM

Trailing 12 months

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

FDA records show no clearances under product code KZM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KZM, 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