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FDA 510(k)

SIEMENS STEREODYNATOR 828

K-Number: K881431 · 1990-04-16

ApplicantElmed, Inc.
Decision Date1990-04-16
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SIEMENS STEREODYNATOR 828 is the device name listed in this FDA 510(k) record. The listed applicant is Elmed, Inc.. It received FDA 510(k) clearance on 1990-04-16 under 510(k) number K881431. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIEMENS STEREODYNATOR 828?

SIEMENS STEREODYNATOR 828 is a medical device that received FDA 510(k) clearance on 1990-04-16. The listed applicant is Elmed, Inc.. The 510(k) number is K881431.

When did SIEMENS STEREODYNATOR 828 receive FDA 510(k) clearance?

SIEMENS STEREODYNATOR 828 received FDA 510(k) clearance on 1990-04-16, under 510(k) number K881431.

Who is the listed applicant for SIEMENS STEREODYNATOR 828?

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

What is the FDA product code for SIEMENS STEREODYNATOR 828?

The FDA product code for SIEMENS STEREODYNATOR 828 is IPF.

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Other records listing Elmed, 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.

K010465DENSTATK974793ELMED ESU 120 M/M DIGITALK953271ELMED RF-ALERTK952110ELMED THERMO-FLUXK926517ELMED LBC 50-PK932938ELMED ESU 300 M/M AND DIGITAL

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Related Devices (Code: IPF)

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.

K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.K252816High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali NezakatiK260142StimelMD (SSMD) systemMotion Informatics ltd.K251083Compact IIEnraf-Nonius, B.V.K241433EVE Synergy (EVE-20M)Weero Co., Ltd.K241488TrainFES AdvanceTrainfes

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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