Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PHONAK MICROZOOM P 2

K-Number: K972097 · 1997-07-30

ApplicantPhonak, Inc.
Decision Date1997-07-30
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PHONAK MICROZOOM P 2 is the device name listed in this FDA 510(k) record. The listed applicant is Phonak, Inc.. It received FDA 510(k) clearance on 1997-07-30 under 510(k) number K972097. 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 PHONAK MICROZOOM P 2?

PHONAK MICROZOOM P 2 is a medical device that received FDA 510(k) clearance on 1997-07-30. The listed applicant is Phonak, Inc.. The 510(k) number is K972097.

When did PHONAK MICROZOOM P 2 receive FDA 510(k) clearance?

PHONAK MICROZOOM P 2 received FDA 510(k) clearance on 1997-07-30, under 510(k) number K972097.

Who is the listed applicant for PHONAK MICROZOOM P 2?

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

What is the FDA product code for PHONAK MICROZOOM P 2?

The FDA product code for PHONAK MICROZOOM P 2 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 Phonak, 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.

K972106PHONAK NOVO FORTE E3K972105PHONAK EPICAK964035PHONAK MICROLINK, PERSONAL FM RECEIVERK961653PHONAK SONA P2K961622PHONAK PICONET2 P2 AZK953921PHONAK 9900 CIC

View all 37 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.

↑