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FDA 510(k)

DRM 2300 PLETHYSMOGRAPHIC CARDIOTACHOMETER

K-Number: K871149 · 1987-06-05

ApplicantIontec Corp.
Decision Date1987-06-05
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DRM 2300 PLETHYSMOGRAPHIC CARDIOTACHOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Iontec Corp.. It received FDA 510(k) clearance on 1987-06-05 under 510(k) number K871149. 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 DRM 2300 PLETHYSMOGRAPHIC CARDIOTACHOMETER?

DRM 2300 PLETHYSMOGRAPHIC CARDIOTACHOMETER is a medical device that received FDA 510(k) clearance on 1987-06-05. The listed applicant is Iontec Corp.. The 510(k) number is K871149.

When did DRM 2300 PLETHYSMOGRAPHIC CARDIOTACHOMETER receive FDA 510(k) clearance?

DRM 2300 PLETHYSMOGRAPHIC CARDIOTACHOMETER received FDA 510(k) clearance on 1987-06-05, under 510(k) number K871149.

Who is the listed applicant for DRM 2300 PLETHYSMOGRAPHIC CARDIOTACHOMETER?

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

What is the FDA product code for DRM 2300 PLETHYSMOGRAPHIC CARDIOTACHOMETER?

The FDA product code for DRM 2300 PLETHYSMOGRAPHIC CARDIOTACHOMETER is DRT.

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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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

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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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