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FDA 510(k)

RASTRONICS CCI 8

K-Number: K902244 · 1990-10-05

ApplicantRastronics USA, Inc.
Decision Date1990-10-05
Product CodeETW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

RASTRONICS CCI 8 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 1990-10-05 under 510(k) number K902244. 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 RASTRONICS CCI 8?

RASTRONICS CCI 8 is a medical device that received FDA 510(k) clearance on 1990-10-05. The listed applicant is Rastronics USA, Inc.. The 510(k) number is K902244.

When did RASTRONICS CCI 8 receive FDA 510(k) clearance?

RASTRONICS CCI 8 received FDA 510(k) clearance on 1990-10-05, under 510(k) number K902244.

Who is the listed applicant for RASTRONICS CCI 8?

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 RASTRONICS CCI 8?

The FDA product code for RASTRONICS CCI 8 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.

K902252RASTRONICS CCI 10/3 HEARING AID ANALYSISK902287RASTRONICS PORTAREM 20K890864HANDTYMP SCREENER MODEL 2000 + 2002 REMOTE TRANS.K853320FREQUENCY RESPONSE ANALYZER COMPUTER SYS CCI-10

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

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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