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FDA 510(k)

FREQUENCY RESPONSE ANALYZER COMPUTER SYS CCI-10

K-Number: K853320 · 1985-09-27

ApplicantRastronics USA, Inc.
Decision Date1985-09-27
Product CodeETW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

FREQUENCY RESPONSE ANALYZER COMPUTER SYS CCI-10 is the device name listed in this FDA 510(k) record. The listed applicant is Rastronics USA, Inc.. It received FDA 510(k) clearance on 1985-09-27 under 510(k) number K853320. The device is classified under product code ETW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FREQUENCY RESPONSE ANALYZER COMPUTER SYS CCI-10?

FREQUENCY RESPONSE ANALYZER COMPUTER SYS CCI-10 is a medical device that received FDA 510(k) clearance on 1985-09-27. The listed applicant is Rastronics USA, Inc.. The 510(k) number is K853320.

When did FREQUENCY RESPONSE ANALYZER COMPUTER SYS CCI-10 receive FDA 510(k) clearance?

FREQUENCY RESPONSE ANALYZER COMPUTER SYS CCI-10 received FDA 510(k) clearance on 1985-09-27, under 510(k) number K853320.

Who is the listed applicant for FREQUENCY RESPONSE ANALYZER COMPUTER SYS CCI-10?

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

What is the FDA product code for FREQUENCY RESPONSE ANALYZER COMPUTER SYS CCI-10?

The FDA product code for FREQUENCY RESPONSE ANALYZER COMPUTER SYS CCI-10 is ETW.

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 Rastronics USA, 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.

K902244RASTRONICS CCI 8K902252RASTRONICS CCI 10/3 HEARING AID ANALYSISK902287RASTRONICS PORTAREM 20K890864HANDTYMP SCREENER MODEL 2000 + 2002 REMOTE TRANS.

Related Devices (Code: ETW)

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.

K122028AURICAL HITGn OtometricsK113831PRIMUS HEARING INSTRUMENT TEST UNITAuditdata A/SK110286GN OTOMETRICS TYPE 1053 FREEFITGn Otometrics A/SK093006FONIX ,MODEL 8000Frye Electronics, Inc.K071462UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)Siemens Hearing Instruments, Inc.K061104SPEECHLINK 100 TYPE 1053Gn Otometrics A/S

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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