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FDA 510(k)

MODEL UCA / SPEC SYSTEM UCA

K-Number: K875305 · 1988-01-27

ApplicantSpec Systems, Inc.
Decision Date1988-01-27
Product CodeFZH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL UCA / SPEC SYSTEM UCA is the device name listed in this FDA 510(k) record. The listed applicant is Spec Systems, Inc.. It received FDA 510(k) clearance on 1988-01-27 under 510(k) number K875305. The device is classified under product code FZH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL UCA / SPEC SYSTEM UCA?

MODEL UCA / SPEC SYSTEM UCA is a medical device that received FDA 510(k) clearance on 1988-01-27. The listed applicant is Spec Systems, Inc.. The 510(k) number is K875305.

When did MODEL UCA / SPEC SYSTEM UCA receive FDA 510(k) clearance?

MODEL UCA / SPEC SYSTEM UCA received FDA 510(k) clearance on 1988-01-27, under 510(k) number K875305.

Who is the listed applicant for MODEL UCA / SPEC SYSTEM UCA?

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

What is the FDA product code for MODEL UCA / SPEC SYSTEM UCA?

The FDA product code for MODEL UCA / SPEC SYSTEM UCA is FZH.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Spec Systems, 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.

K821165SONIC MODEL 8711 HEARING AID

Related Devices (Code: FZH)

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.

K923233CARDIO-PAK LAPAROTOMY PACKCardio-Med-Associates, Inc.K871901ULTRAFLOWCustom Industries, Inc.K770084OPERATING ROOM VENTILATORDupaco, Inc.

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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