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FDA 510(k)

MO4 SERIES

K-Number: K944404 · 1994-12-27

ApplicantPhilips Hearing Instruments Co.
Decision Date1994-12-27
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MO4 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Philips Hearing Instruments Co.. It received FDA 510(k) clearance on 1994-12-27 under 510(k) number K944404. 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 MO4 SERIES?

MO4 SERIES is a medical device that received FDA 510(k) clearance on 1994-12-27. The listed applicant is Philips Hearing Instruments Co.. The 510(k) number is K944404.

When did MO4 SERIES receive FDA 510(k) clearance?

MO4 SERIES received FDA 510(k) clearance on 1994-12-27, under 510(k) number K944404.

Who is the listed applicant for MO4 SERIES?

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

What is the FDA product code for MO4 SERIES?

The FDA product code for MO4 SERIES 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 Philips Hearing Instruments 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.

K972818D72 DIGITALK971804PHILIPS S1694, S1695K965088M11 SERIES: M11, M11MK961770PHILIPS 71 SERIESK952658HEARING AIDK943670MO6 SERIES

View all 20 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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