FDA 510(k)

ALGO I

K-Number: K852687 · 1985-09-18

Decision Date1985-09-18

Product CodeGWJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

ALGO I is the device name listed in this FDA 510(k) record. The listed applicant is Algotek, Inc.. It received FDA 510(k) clearance on 1985-09-18 under 510(k) number K852687. The device is classified under product code GWJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALGO I?

ALGO I is a medical device that received FDA 510(k) clearance on 1985-09-18. The listed applicant is Algotek, Inc.. The 510(k) number is K852687.

When did ALGO I receive FDA 510(k) clearance?

ALGO I received FDA 510(k) clearance on 1985-09-18, under 510(k) number K852687.

Who is the listed applicant for ALGO I?

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

What is the FDA product code for ALGO I?

The FDA product code for ALGO I is GWJ.

Other records listing Algotek, 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.

K864408EMG-1, MOTOR NERVE MONITOR

Related Devices (Code: GWJ)

K242954Integrity V500 (Integrity, Integrity with VEMP)Vivosonic, Inc.K233649ALGO Pro Newborn Hearing Screener (ALGO Pro)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)K220139QScreenPath Medical GmbH K211147ALGO 7iPath Medical GmbH K193033GSI Audera ProGrason Stadler K163326SmartEPIntelligent Hearing Systems

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.