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FDA 510(k)

MINI-CISER

K-Number: K974848 · 1998-08-06

ApplicantHougen Mfg., Inc.
Decision Date1998-08-06
Product CodeBWF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MINI-CISER is the device name listed in this FDA 510(k) record. The listed applicant is Hougen Mfg., Inc.. It received FDA 510(k) clearance on 1998-08-06 under 510(k) number K974848. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MINI-CISER?

MINI-CISER is a medical device that received FDA 510(k) clearance on 1998-08-06. The listed applicant is Hougen Mfg., Inc.. The 510(k) number is K974848.

When did MINI-CISER receive FDA 510(k) clearance?

MINI-CISER received FDA 510(k) clearance on 1998-08-06, under 510(k) number K974848.

Who is the listed applicant for MINI-CISER?

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

What is the FDA product code for MINI-CISER?

The FDA product code for MINI-CISER is BWF.

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 Hougen Mfg., 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.

K974849X-AIR-CISER

Related Devices (Code: BWF)

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

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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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