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FDA 510(k)

TWIST PPAGC-1, TWIST PP

K-Number: K972543 · 1997-07-23

ApplicantTrutone
Decision Date1997-07-23
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TWIST PPAGC-1, TWIST PP is the device name listed in this FDA 510(k) record. The listed applicant is Trutone. It received FDA 510(k) clearance on 1997-07-23 under 510(k) number K972543. 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 TWIST PPAGC-1, TWIST PP?

TWIST PPAGC-1, TWIST PP is a medical device that received FDA 510(k) clearance on 1997-07-23. The listed applicant is Trutone. The 510(k) number is K972543.

When did TWIST PPAGC-1, TWIST PP receive FDA 510(k) clearance?

TWIST PPAGC-1, TWIST PP received FDA 510(k) clearance on 1997-07-23, under 510(k) number K972543.

Who is the listed applicant for TWIST PPAGC-1, TWIST PP?

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

What is the FDA product code for TWIST PPAGC-1, TWIST PP?

The FDA product code for TWIST PPAGC-1, TWIST PP is ESD.

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 Trutone 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.

K973377SIBELMED AC50DK972550AUDIFON H24 AGC/AUDIFON H25 AGC/AUDIFON H30 AGCK972552AUDIFON H20 PC/AUDIFON H32 PPK972542JAZZ PP AGC-O, JAZZ PP

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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