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FDA 510(k)

OMRON MASSAGER MODEL HM-45

K-Number: K935459 · 1994-03-04

ApplicantOmron Healthcare, Inc.
Decision Date1994-03-04
Product CodeISA
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

OMRON MASSAGER MODEL HM-45 is the device name listed in this FDA 510(k) record. The listed applicant is Omron Healthcare, Inc.. It received FDA 510(k) clearance on 1994-03-04 under 510(k) number K935459. The device is classified under product code ISA. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMRON MASSAGER MODEL HM-45?

OMRON MASSAGER MODEL HM-45 is a medical device that received FDA 510(k) clearance on 1994-03-04. The listed applicant is Omron Healthcare, Inc.. The 510(k) number is K935459.

When did OMRON MASSAGER MODEL HM-45 receive FDA 510(k) clearance?

OMRON MASSAGER MODEL HM-45 received FDA 510(k) clearance on 1994-03-04, under 510(k) number K935459.

Who is the listed applicant for OMRON MASSAGER MODEL HM-45?

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

What is the FDA product code for OMRON MASSAGER MODEL HM-45?

The FDA product code for OMRON MASSAGER MODEL HM-45 is ISA.

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Other records listing Omron Healthcare, Inc. as applicant

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Related Devices (Code: ISA)

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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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