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FDA 510(k)

OMED IDENT-I-BAND

K-Number: K830484 · 1983-03-24

ApplicantOmega-Med Intl., Inc.
Decision Date1983-03-24
Product Code
DecisionSubstantially Equivalent

Device Summary

OMED IDENT-I-BAND is the device name listed in this FDA 510(k) record. The listed applicant is Omega-Med Intl., Inc.. It received FDA 510(k) clearance on 1983-03-24 under 510(k) number K830484. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMED IDENT-I-BAND?

OMED IDENT-I-BAND is a medical device that received FDA 510(k) clearance on 1983-03-24. The listed applicant is Omega-Med Intl., Inc.. The 510(k) number is K830484.

When did OMED IDENT-I-BAND receive FDA 510(k) clearance?

OMED IDENT-I-BAND received FDA 510(k) clearance on 1983-03-24, under 510(k) number K830484.

Who is the listed applicant for OMED IDENT-I-BAND?

The FDA 510(k) record lists Omega-Med Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

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Other records listing Omega-Med Intl., 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.

K842603OMED DISPOS. INSTRUMENT GUARDSK832441SUTURE-AID BOOTIESK822284COMPLY NEUROMUSCULAR STIMULATORK821334OMED FABRIC INSTRUMENT COVERS-RADIOPAQK813499OMED DISPOSABLE BULLDOGK810883OMED SILICONE INSTRUMENT COVERS

View all 9 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.

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