LENSCHEK— 510(k) K944022

Substantially Equivalent

Leica, Inc.

FDA 510(k) clearance K944022 for LENSCHEK, Substantially Equivalent on 1994-11-17. Applicant: Leica, Inc.. Device class: 1.

Clearance details

Applicant: Leica, Inc.
Product code: Code HLM
Device class: Class 1
Regulation: 21 CFR 886.1425
Advisory panel: Ophthalmic
Date received: 1994-08-17
Decision date: 1994-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HLM

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K936199 — AUTOMATIC LENSOMETER1994-09-28
K930441 — MARCO STANDARD LENSMETERS 101,2011993-07-06
K930445 — MARCO LM-770 DIGITAL PROJECTION LENSMETER1993-06-21
K924776 — BURTON LENSMETER - MODEL 20211993-04-05

More clearances from Leica, Inc.

K951054 — XCEL SLIT LAMP1995-03-22
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Data sourced from openFDA. This site is unofficial and independent of the FDA.