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FDA 510(k)

DAVOL EMS ADAPTER, CAT. NO. 13-7664

K-Number: K800317 · 1980-03-12

ApplicantElectrocaine Medical System
Decision Date1980-03-12
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DAVOL EMS ADAPTER, CAT. NO. 13-7664 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 1980-03-12 under 510(k) number K800317. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DAVOL EMS ADAPTER, CAT. NO. 13-7664?

DAVOL EMS ADAPTER, CAT. NO. 13-7664 is a medical device that received FDA 510(k) clearance on 1980-03-12. The listed applicant is Electrocaine Medical System. The 510(k) number is K800317.

When did DAVOL EMS ADAPTER, CAT. NO. 13-7664 receive FDA 510(k) clearance?

DAVOL EMS ADAPTER, CAT. NO. 13-7664 received FDA 510(k) clearance on 1980-03-12, under 510(k) number K800317.

Who is the listed applicant for DAVOL EMS ADAPTER, CAT. NO. 13-7664?

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 DAVOL EMS ADAPTER, CAT. NO. 13-7664?

The FDA product code for DAVOL EMS ADAPTER, CAT. NO. 13-7664 is GEI.

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.

K924413FLOWSCANK926336AUDIOSCANK844638ELECTROCAINE MODEL SR-IVK830992XCEL MODEL XE-1

Related Devices (Code: GEI)

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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