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FDA 510(k)

EMISONIC 4201

K-Number: K781051 · 1978-07-17

ApplicantEmi Medical, Inc.
Decision Date1978-07-17
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EMISONIC 4201 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 1978-07-17 under 510(k) number K781051. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMISONIC 4201?

EMISONIC 4201 is a medical device that received FDA 510(k) clearance on 1978-07-17. The listed applicant is Emi Medical, Inc.. The 510(k) number is K781051.

When did EMISONIC 4201 receive FDA 510(k) clearance?

EMISONIC 4201 received FDA 510(k) clearance on 1978-07-17, under 510(k) number K781051.

Who is the listed applicant for EMISONIC 4201?

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 EMISONIC 4201?

The FDA product code for EMISONIC 4201 is IYO.

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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.

K791429EMISONIC 4290K781936SCANNER-EMI 7020 AND 7020RK781519EMI SIMULATOR REMOTE CONTROL CONSOLEK780995COMPUTERIZED AXIAL TOMOGRAPHYK780928CT5137 HIGH RESOLUTION OPTIONK7809305543 INDEPENDENT VIEWING SYSTEM

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Related Devices (Code: IYO)

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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