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FDA 510(k)

HANDTYMP SCREENER MODEL 2000 + 2002 REMOTE TRANS.

K-Number: K890864 · 1989-06-21

ApplicantRastronics USA, Inc.
Decision Date1989-06-21
Product CodeETY
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HANDTYMP SCREENER MODEL 2000 + 2002 REMOTE TRANS. 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 1989-06-21 under 510(k) number K890864. The device is classified under product code ETY. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HANDTYMP SCREENER MODEL 2000 + 2002 REMOTE TRANS.?

HANDTYMP SCREENER MODEL 2000 + 2002 REMOTE TRANS. is a medical device that received FDA 510(k) clearance on 1989-06-21. The listed applicant is Rastronics USA, Inc.. The 510(k) number is K890864.

When did HANDTYMP SCREENER MODEL 2000 + 2002 REMOTE TRANS. receive FDA 510(k) clearance?

HANDTYMP SCREENER MODEL 2000 + 2002 REMOTE TRANS. received FDA 510(k) clearance on 1989-06-21, under 510(k) number K890864.

Who is the listed applicant for HANDTYMP SCREENER MODEL 2000 + 2002 REMOTE TRANS.?

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 HANDTYMP SCREENER MODEL 2000 + 2002 REMOTE TRANS.?

The FDA product code for HANDTYMP SCREENER MODEL 2000 + 2002 REMOTE TRANS. is ETY.

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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 20K853320FREQUENCY RESPONSE ANALYZER COMPUTER SYS CCI-10

Related Devices (Code: ETY)

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.

K183201Hearing Healthcare ProDb Diagnostic Systems, Inc.K171038Hearing Healthcare ProDb Diagnostic Systems, Inc.K162210touchTympMaico Diagnostics GmbHK161707Madsen ZodiacGn OtometricsK121847TITANInteracoustics A/SK083861TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITEInteracoustics AS

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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