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FDA 510(k)

SIRECUST MODEL 960 AND 961 PATIENT MONITORING

K-Number: K872249 · 1987-07-21

ApplicantMedical Electronics Laboratories, Inc.
Decision Date1987-07-21
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SIRECUST MODEL 960 AND 961 PATIENT MONITORING is the device name listed in this FDA 510(k) record. The listed applicant is Medical Electronics Laboratories, Inc.. It received FDA 510(k) clearance on 1987-07-21 under 510(k) number K872249. 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 SIRECUST MODEL 960 AND 961 PATIENT MONITORING?

SIRECUST MODEL 960 AND 961 PATIENT MONITORING is a medical device that received FDA 510(k) clearance on 1987-07-21. The listed applicant is Medical Electronics Laboratories, Inc.. The 510(k) number is K872249.

When did SIRECUST MODEL 960 AND 961 PATIENT MONITORING receive FDA 510(k) clearance?

SIRECUST MODEL 960 AND 961 PATIENT MONITORING received FDA 510(k) clearance on 1987-07-21, under 510(k) number K872249.

Who is the listed applicant for SIRECUST MODEL 960 AND 961 PATIENT MONITORING?

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

What is the FDA product code for SIRECUST MODEL 960 AND 961 PATIENT MONITORING?

The FDA product code for SIRECUST MODEL 960 AND 961 PATIENT MONITORING 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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Other records listing Medical Electronics Laboratories, 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.

K873533SIEMENS SIRECUST 1280, 1281 W/ARRHYTHMIA SOFTWARE

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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