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FDA 510(k)

INPOUCH-TV POUCH

K-Number: K896296 · 1990-01-29

ApplicantBiomed Diagnostics, Inc.
Decision Date1990-01-29
Product CodeJSN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

INPOUCH-TV POUCH is the device name listed in this FDA 510(k) record. The listed applicant is Biomed Diagnostics, Inc.. It received FDA 510(k) clearance on 1990-01-29 under 510(k) number K896296. The device is classified under product code JSN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INPOUCH-TV POUCH?

INPOUCH-TV POUCH is a medical device that received FDA 510(k) clearance on 1990-01-29. The listed applicant is Biomed Diagnostics, Inc.. The 510(k) number is K896296.

When did INPOUCH-TV POUCH receive FDA 510(k) clearance?

INPOUCH-TV POUCH received FDA 510(k) clearance on 1990-01-29, under 510(k) number K896296.

Who is the listed applicant for INPOUCH-TV POUCH?

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

What is the FDA product code for INPOUCH-TV POUCH?

The FDA product code for INPOUCH-TV POUCH is JSN.

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 Biomed Diagnostics, 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.

K993033INTRAY GC

Related Devices (Code: JSN)

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.

K000718CHROMOSTREAKNovamed , Ltd.K962745ENTERIC PATHOGEN TRANSPORT (EPT) (E1020,E1000)Prepared Media Laboratory, Inc.K961755CYTOQUANT CHLAMYDIA TRANSPORT MEDIUMProteins Intl., Inc.K961756CYTOQUANT VIRAL TRANSPORT MEDIUMProteins Intl., Inc.K881579AMIES TRANSPORT MEDIUM W/O CHARCOALAcumedia Manufacturers, Inc.K860967VIRTRAN VIRAL TRANSPORTER (MODIFIED)Diagnon Corp.

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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