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FDA 510(k)

ACUDATA INDICATENS MODEL 5M

K-Number: K890087 · 1989-09-07

ApplicantAcudata Software
Decision Date1989-09-07
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ACUDATA INDICATENS MODEL 5M is the device name listed in this FDA 510(k) record. The listed applicant is Acudata Software. It received FDA 510(k) clearance on 1989-09-07 under 510(k) number K890087. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUDATA INDICATENS MODEL 5M?

ACUDATA INDICATENS MODEL 5M is a medical device that received FDA 510(k) clearance on 1989-09-07. The listed applicant is Acudata Software. The 510(k) number is K890087.

When did ACUDATA INDICATENS MODEL 5M receive FDA 510(k) clearance?

ACUDATA INDICATENS MODEL 5M received FDA 510(k) clearance on 1989-09-07, under 510(k) number K890087.

Who is the listed applicant for ACUDATA INDICATENS MODEL 5M?

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

What is the FDA product code for ACUDATA INDICATENS MODEL 5M?

The FDA product code for ACUDATA INDICATENS MODEL 5M is GZJ.

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Other records listing Acudata Software 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.

K900668ACUDATA INDICATENS MODEL 5XSK900596ACUDATA INDICATENS MODEL 5AK890088ACUDATA INDICATENS MODEL 5XK891105INDICATENS MODEL 4X4 SP ELECTRODE STIM. PATCHESK891107INDICATENS INDICATOR ELECTRODE MODEL 2K881708INDICATENS 4X4

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Related Devices (Code: GZJ)

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.

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimedK252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLCK232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical OfficerK233046Electrical Neuromuscular Stimulator, Cure TrioOriental Inspiration Limited

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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