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FDA 510(k)

MODEL 118 PULSE MEGASON

K-Number: K800632 · 1980-05-02

Decision Date1980-05-02
Product CodeIMI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MODEL 118 PULSE MEGASON is the device name listed in this FDA 510(k) record. The listed applicant is Birtcher Corp.. It received FDA 510(k) clearance on 1980-05-02 under 510(k) number K800632. The device is classified under product code IMI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 118 PULSE MEGASON?

MODEL 118 PULSE MEGASON is a medical device that received FDA 510(k) clearance on 1980-05-02. The listed applicant is Birtcher Corp.. The 510(k) number is K800632.

When did MODEL 118 PULSE MEGASON receive FDA 510(k) clearance?

MODEL 118 PULSE MEGASON received FDA 510(k) clearance on 1980-05-02, under 510(k) number K800632.

Who is the listed applicant for MODEL 118 PULSE MEGASON?

The FDA 510(k) record lists Birtcher Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL 118 PULSE MEGASON?

The FDA product code for MODEL 118 PULSE MEGASON is IMI.

Related Clinical Trials

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.

Other records listing Birtcher Corp. 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.

View all 27 devices →

Related Devices (Code: IMI)

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.

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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