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FDA 510(k)

ES1600 PARAMEDIC TELEPHONE

K-Number: K912281 · 1991-11-19

ApplicantEpic Systems, Inc.
Decision Date1991-11-19
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ES1600 PARAMEDIC TELEPHONE is the device name listed in this FDA 510(k) record. The listed applicant is Epic Systems, Inc.. It received FDA 510(k) clearance on 1991-11-19 under 510(k) number K912281. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ES1600 PARAMEDIC TELEPHONE?

ES1600 PARAMEDIC TELEPHONE is a medical device that received FDA 510(k) clearance on 1991-11-19. The listed applicant is Epic Systems, Inc.. The 510(k) number is K912281.

When did ES1600 PARAMEDIC TELEPHONE receive FDA 510(k) clearance?

ES1600 PARAMEDIC TELEPHONE received FDA 510(k) clearance on 1991-11-19, under 510(k) number K912281.

Who is the listed applicant for ES1600 PARAMEDIC TELEPHONE?

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

What is the FDA product code for ES1600 PARAMEDIC TELEPHONE?

The FDA product code for ES1600 PARAMEDIC TELEPHONE is DXH. This falls under the Hematology category.

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 Epic 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.

K922783ES1700 ECG MODULATORK921699ES 1500 ECG DEMODULATOR

Related Devices (Code: DXH)

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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