KEELER ACU 22XT OPHTHALMIC CRYO UNIT— 510(k) K874555

Name: FDA 510(k) clearance K874555
Creator: U.S. Food and Drug Administration
Published: 1988-01-29

Substantially Equivalent

Keeler Instruments, Inc.

FDA 510(k) clearance K874555 for KEELER ACU 22XT OPHTHALMIC CRYO UNIT, Substantially Equivalent on 1988-01-29. Applicant: Keeler Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Keeler Instruments, Inc.
Product code: Code HPS
Device class: Class 2
Regulation: 21 CFR 886.4170
Advisory panel: Ophthalmic
Date received: 1987-11-04
Decision date: 1988-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Broomall, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HPS

view all

K202038 — CryoTreQ2020-12-30
K940373 — OPHTHALMIC CRYO UNIT1994-07-18
K923629 — OPHTHALMIC TRICHIASIS PROBE1992-10-19
K903303 — SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES1990-10-11
K873388 — KEELER CTU CRYO SYSTEM1987-11-13

More clearances from Keeler Instruments, Inc.

view all

K181143 — Keeler TonoCare Tonometer2019-02-08
K112093 — CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER2011-12-08
K093298 — PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-20002010-12-10
K100500 — PSL CLASSIC SLIT LAMP2010-03-09
K062412 — CRYOMATIC2006-11-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.