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FDA 510(k)

RASTRONICS PORTAREM 20

K-Number: K902287 · 1990-08-09

ApplicantRastronics USA, Inc.
Decision Date1990-08-09
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RASTRONICS PORTAREM 20 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 1990-08-09 under 510(k) number K902287. The device is classified under product code EJT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RASTRONICS PORTAREM 20?

RASTRONICS PORTAREM 20 is a medical device that received FDA 510(k) clearance on 1990-08-09. The listed applicant is Rastronics USA, Inc.. The 510(k) number is K902287.

When did RASTRONICS PORTAREM 20 receive FDA 510(k) clearance?

RASTRONICS PORTAREM 20 received FDA 510(k) clearance on 1990-08-09, under 510(k) number K902287.

Who is the listed applicant for RASTRONICS PORTAREM 20?

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 PORTAREM 20?

The FDA product code for RASTRONICS PORTAREM 20 is EJT.

Related Clinical Trials

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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 ANALYSISK890864HANDTYMP SCREENER MODEL 2000 + 2002 REMOTE TRANS.K853320FREQUENCY RESPONSE ANALYZER COMPUTER SYS CCI-10

Related Devices (Code: EJT)

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.

K052463PROMETAL HN86Prometal TechnologiesK041378BIO 60Kodent, Inc.K040672PORTA REFLEXWieland Dental + Technik GmbH & Co. KGK040524PORTA SOLDER 1090 WWieland Dental + Technik GmbH & Co. KGK040043NDX-40 ALLOYHeraeus Kulzer, Inc.K034049HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORMHeraeus Kulzer,GmbH

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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