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FDA 510(k)

PRISM

K-Number: K932480 · 1993-07-21

ApplicantBio Clinic Co.
Decision Date1993-07-21
Product CodeIOQ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PRISM is the device name listed in this FDA 510(k) record. The listed applicant is Bio Clinic Co.. It received FDA 510(k) clearance on 1993-07-21 under 510(k) number K932480. The device is classified under product code IOQ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRISM?

PRISM is a medical device that received FDA 510(k) clearance on 1993-07-21. The listed applicant is Bio Clinic Co.. The 510(k) number is K932480.

When did PRISM receive FDA 510(k) clearance?

PRISM received FDA 510(k) clearance on 1993-07-21, under 510(k) number K932480.

Who is the listed applicant for PRISM?

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

What is the FDA product code for PRISM?

The FDA product code for PRISM is IOQ.

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Related PubMed Literature

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.

PMID: 41827353Clinical Trial Design and Regulatory Requirements for Artificial Intelligence as a Medical Device: A PRISMA-ScR-Guided Scoping Review of Global Guidance and Evidence (2017-2025).Journal of clinical medicine ()

Other records listing Bio Clinic Co. 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.

K930791AMERICAN POWER CONVERSIONS, BACK-UPS 600K926189ORTHODERM CONSUMMATE AIR THERAPY BED W/SCALEK921958ELISA TUBE TSH TESTK922140ORTHODERM CONVERTIBLE IIK921212MIRCO ELISA HPL TEST KITK921211NOW PREGNANCY TEST KIT

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Related Devices (Code: IOQ)

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.

K122473TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2Hill-RomK973624NURSE'S AID PATIENT ROTATION SYSTEMAir Med Assist ProductsK970364AIRTEC2 LOW AIR LOSS THERAPY BEDApex Metal, Inc.K970363HYDROTEC LOW AIR LOSS THERAPY BEDApex Metal, Inc.K970636TOTALCARE., MODULAR THERAPY SYSTEM (MTS)Hill-Rom, Inc.K964873SILKAIR LOW AIRLOSS THERAPYHill-Rom, Inc.

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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