510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K850007Substantially Equivalent

Acoustic Otocope Recorder

Endeco Medical, Inc., Marion MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850007 is the FDA 510(k) clearance record for ACOUSTIC OTOCOPE RECORDER, a class II device, cleared for Endeco Medical, Inc. on under FDA product code ETY (Tester, Auditory Impedance). FDA records list 2 510(k) clearances for Endeco Medical, Inc., from to . As of , FDA records show no recalls naming K850007.

Clearance record

Decision date
Received
(58 days to decision)
Product code
ETY Tester, Auditory Impedance
Regulation
21 CFR 874.1090
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Endeco Medical, Inc. 13 Atlantis Dr., Marion MA
Third party review
No

Clearances, product code ETY

Trailing 12 months

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

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