510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K882575Substantially Equivalent

Distometer

Hagg-Streit Service, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882575 is the FDA 510(k) clearance record for DISTOMETER, a class I device, cleared for Hagg-Streit Service, Inc. on under FDA product code HMM (Distometer). FDA records list 2 510(k) clearances for Hagg-Streit Service, Inc., from to . As of , FDA records show no recalls naming K882575.

Clearance record

Decision date
Received
(9 days to decision)
Product code
HMM Distometer
Regulation
21 CFR 886.1190
Device class
Class I
Review panel
Ophthalmic
Applicant
Hagg-Streit Service, Inc. 1050 Connecticut Ave., NW, Washington DC
Third party review
No

Clearances, product code HMM

Trailing 12 months

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

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