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FDA 510(k)

PRISMA

K-Number: K972998 · 1997-09-05

ApplicantSiemens Hearing Instruments, Inc.
Decision Date1997-09-05
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PRISMA is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Hearing Instruments, Inc.. It received FDA 510(k) clearance on 1997-09-05 under 510(k) number K972998. The device is classified under product code ESD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRISMA?

PRISMA is a medical device that received FDA 510(k) clearance on 1997-09-05. The listed applicant is Siemens Hearing Instruments, Inc.. The 510(k) number is K972998.

When did PRISMA receive FDA 510(k) clearance?

PRISMA received FDA 510(k) clearance on 1997-09-05, under 510(k) number K972998.

Who is the listed applicant for PRISMA?

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

What is the FDA product code for PRISMA?

The FDA product code for PRISMA is ESD.

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Related PubMed Literature

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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 Siemens Hearing Instruments, 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.

K071462UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)K011364CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)K011366CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)K003559TCI (TINNITUS CONTROL INSTRUMENT)K003558TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)K962170SIEMENS VITA 160 SERIES POCKET HEARING INSTRUMENT: VITA 162E,166M,168PP

View all 42 devices →

Related Devices (Code: ESD)

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.

K232999Lyric4 Hearing AidSonova AGK130790LYRIC2Phonak, LLCK081136LYRIC HEARING AIDInsound Medical, Inc.K021867INSOUND XT SERIES HEARING AIDInsound Medical, Inc.K003558TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)Siemens Hearing Instruments, Inc.K984518SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELLSonic Innovations, 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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