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FDA 510(k)

VISTA V-38 CIC

K-Number: K970939 · 1997-06-06

ApplicantVista Labs
Decision Date1997-06-06
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

VISTA V-38 CIC is the device name listed in this FDA 510(k) record. The listed applicant is Vista Labs. It received FDA 510(k) clearance on 1997-06-06 under 510(k) number K970939. 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 VISTA V-38 CIC?

VISTA V-38 CIC is a medical device that received FDA 510(k) clearance on 1997-06-06. The listed applicant is Vista Labs. The 510(k) number is K970939.

When did VISTA V-38 CIC receive FDA 510(k) clearance?

VISTA V-38 CIC received FDA 510(k) clearance on 1997-06-06, under 510(k) number K970939.

Who is the listed applicant for VISTA V-38 CIC?

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

What is the FDA product code for VISTA V-38 CIC?

The FDA product code for VISTA V-38 CIC 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.

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Other records listing Vista Labs 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.

K972755V-12 LONG LIFE 675 HEARING AID

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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