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FDA 510(k)

ELECTROCAINE MODEL SR-IV

K-Number: K844638 · 1985-01-08

ApplicantElectrocaine Medical System
Decision Date1985-01-08
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ELECTROCAINE MODEL SR-IV is the device name listed in this FDA 510(k) record. The listed applicant is Electrocaine Medical System. It received FDA 510(k) clearance on 1985-01-08 under 510(k) number K844638. 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 ELECTROCAINE MODEL SR-IV?

ELECTROCAINE MODEL SR-IV is a medical device that received FDA 510(k) clearance on 1985-01-08. The listed applicant is Electrocaine Medical System. The 510(k) number is K844638.

When did ELECTROCAINE MODEL SR-IV receive FDA 510(k) clearance?

ELECTROCAINE MODEL SR-IV received FDA 510(k) clearance on 1985-01-08, under 510(k) number K844638.

Who is the listed applicant for ELECTROCAINE MODEL SR-IV?

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

What is the FDA product code for ELECTROCAINE MODEL SR-IV?

The FDA product code for ELECTROCAINE MODEL SR-IV is GZJ.

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 Electrocaine Medical System 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.

K924413FLOWSCANK926336AUDIOSCANK830992XCEL MODEL XE-1K800317DAVOL EMS ADAPTER, CAT. NO. 13-7664

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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