Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OMS CRYO

K-Number: K844467 · 1985-02-22

ApplicantOptical Micro Systems, Inc.
Decision Date1985-02-22
Product Code
DecisionSubstantially Equivalent

Device Summary

OMS CRYO is the device name listed in this FDA 510(k) record. The listed applicant is Optical Micro Systems, Inc.. It received FDA 510(k) clearance on 1985-02-22 under 510(k) number K844467. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMS CRYO?

OMS CRYO is a medical device that received FDA 510(k) clearance on 1985-02-22. The listed applicant is Optical Micro Systems, Inc.. The 510(k) number is K844467.

When did OMS CRYO receive FDA 510(k) clearance?

OMS CRYO received FDA 510(k) clearance on 1985-02-22, under 510(k) number K844467.

Who is the listed applicant for OMS CRYO?

The FDA 510(k) record lists Optical Micro Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

Other records listing Optical Micro Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K950218OMS SLIMLINE PHACO HANDPIECEK946054DIPLOMAXK935223OPHTHALMIC SURGICAL SYSTEMK935226I/V POLEK935003ELECTRIC I/V POLE OR EIVP2K870068ASPIRATION REVERSAL CONTROL (ARC) MODULE

View all 21 devices →

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑