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FDA 510(k)

EMI CTR 100

K-Number: K771811 · 1977-10-19

ApplicantEmi Medical, Inc.
Decision Date1977-10-19
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EMI CTR 100 is the device name listed in this FDA 510(k) record. The listed applicant is Emi Medical, Inc.. It received FDA 510(k) clearance on 1977-10-19 under 510(k) number K771811. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMI CTR 100?

EMI CTR 100 is a medical device that received FDA 510(k) clearance on 1977-10-19. The listed applicant is Emi Medical, Inc.. The 510(k) number is K771811.

When did EMI CTR 100 receive FDA 510(k) clearance?

EMI CTR 100 received FDA 510(k) clearance on 1977-10-19, under 510(k) number K771811.

Who is the listed applicant for EMI CTR 100?

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

What is the FDA product code for EMI CTR 100?

The FDA product code for EMI CTR 100 is JAK.

Other records listing Emi Medical, 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.

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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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