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FDA 510(k)

ERGOMED 840/ERGOMED 840L

K-Number: K885085 · 1989-10-03

ApplicantBurdick Corp.
Decision Date1989-10-03
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ERGOMED 840/ERGOMED 840L is the device name listed in this FDA 510(k) record. The listed applicant is Burdick Corp.. It received FDA 510(k) clearance on 1989-10-03 under 510(k) number K885085. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ERGOMED 840/ERGOMED 840L?

ERGOMED 840/ERGOMED 840L is a medical device that received FDA 510(k) clearance on 1989-10-03. The listed applicant is Burdick Corp.. The 510(k) number is K885085.

When did ERGOMED 840/ERGOMED 840L receive FDA 510(k) clearance?

ERGOMED 840/ERGOMED 840L received FDA 510(k) clearance on 1989-10-03, under 510(k) number K885085.

Who is the listed applicant for ERGOMED 840/ERGOMED 840L?

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

What is the FDA product code for ERGOMED 840/ERGOMED 840L?

The FDA product code for ERGOMED 840/ERGOMED 840L is DRT.

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Other records listing Burdick Corp. 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.

K942565ALTAIR-DISC RECORDERK941351BURDICK PRO2 OXIMETERK903565E560 ELECTROCARDIOGRAPHK904032ELITE II ELECTROCARDIOGRAPHK900729NEOSERV 824K892835E350 ELECTROCARDIOGRAPH

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Related Devices (Code: DRT)

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.

K254058DistaSense(TM) (v1)Life Detection TechnologiesK261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, Ltd.

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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