510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921815Substantially Equivalent

Tomey Pe-300 Portable Erg

Tomey Corporation USA, Cambridge MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921815 is the FDA 510(k) clearance record for TOMEY PE-300 PORTABLE ERG, a class II device, cleared for Tomey Corporation USA on under FDA product code HLT (Preamplifier, Ac-Powered, Ophthalmic). FDA records list 9 510(k) clearances for Tomey Corporation USA, from to . As of , FDA records show no recalls naming K921815.

Clearance record

Decision date
Received
(91 days to decision)
Product code
HLT Preamplifier, Ac-Powered, Ophthalmic
Regulation
21 CFR 886.1640
Device class
Class II
Review panel
Ophthalmic
Applicant
Tomey Corporation USA 325 Vassar St. 2nd Floor, Cambridge MA
510(k) summary
Statement
Third party review
No

Clearances, product code HLT

Trailing 12 months

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

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