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FDA 510(k)

STRATUM ESU

K-Number: K874719 · 1988-02-16

ApplicantAlternative Design Systems, Inc.
Decision Date1988-02-16
Product CodeJOS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STRATUM ESU is the device name listed in this FDA 510(k) record. The listed applicant is Alternative Design Systems, Inc.. It received FDA 510(k) clearance on 1988-02-16 under 510(k) number K874719. The device is classified under product code JOS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRATUM ESU?

STRATUM ESU is a medical device that received FDA 510(k) clearance on 1988-02-16. The listed applicant is Alternative Design Systems, Inc.. The 510(k) number is K874719.

When did STRATUM ESU receive FDA 510(k) clearance?

STRATUM ESU received FDA 510(k) clearance on 1988-02-16, under 510(k) number K874719.

Who is the listed applicant for STRATUM ESU?

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

What is the FDA product code for STRATUM ESU?

The FDA product code for STRATUM ESU is JOS.

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 Alternative Design Systems, 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.

K874697STRATUM DK8547575000 SERIES ECG ELECTRODESK853633TENS CONDUCTIVE MEDIA PADK852515ACCESSORY VENTILLARY(BREATHING) FREQUENCY MONITORK830778MONITORING KIT AMK-1

Related Devices (Code: JOS)

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.

K161600Resection ElectrodesOlympus Winter & Ibe GmbHK050923LIGHTWAVE INTEGRATED ELECTRODE ABLATOR AND LIGHT WAVE INTEGRATED ELECTRODE SUCTION ABLATORConmed LinvatecK012684REPROCESSED ELECTROSURGICAL ELECTRODESterilmed, Inc.K011515MEDLINE GROUNDING PADMedline Industries, Inc.K003403ENDOSCOPIC MONOPOLAREECTRODE, MODEL EME- 1000 TO 1999Highland / Marietta, Inc.K000333STANDARD & EXTENDED BLADE, STANDARD & EXTENDED NEEDLE, STANDARD & EXTENDED BALL, MODIFIED STANDARD & EXTENDED BLADE, MODTriad Surgical Technologies, Inc.

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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