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FDA 510(k)

SPACEMISER 8-10 FILM RECORDER

K-Number: K871957 · 1987-06-22

Decision Date1987-06-22
Product CodeLMC
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SPACEMISER 8-10 FILM RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Frantz Imaging, Inc.. It received FDA 510(k) clearance on 1987-06-22 under 510(k) number K871957. The device is classified under product code LMC. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPACEMISER 8-10 FILM RECORDER?

SPACEMISER 8-10 FILM RECORDER is a medical device that received FDA 510(k) clearance on 1987-06-22. The listed applicant is Frantz Imaging, Inc.. The 510(k) number is K871957.

When did SPACEMISER 8-10 FILM RECORDER receive FDA 510(k) clearance?

SPACEMISER 8-10 FILM RECORDER received FDA 510(k) clearance on 1987-06-22, under 510(k) number K871957.

Who is the listed applicant for SPACEMISER 8-10 FILM RECORDER?

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

What is the FDA product code for SPACEMISER 8-10 FILM RECORDER?

The FDA product code for SPACEMISER 8-10 FILM RECORDER is LMC.

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 Frantz Imaging, 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.

Related Devices (Code: LMC)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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