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FDA 510(k)

SIEMENS SIRECUST 1280, 1281 W/ARRHYTHMIA SOFTWARE

K-Number: K873533 · 1988-01-29

ApplicantMedical Electronics Laboratories, Inc.
Decision Date1988-01-29
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SIEMENS SIRECUST 1280, 1281 W/ARRHYTHMIA SOFTWARE 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 1988-01-29 under 510(k) number K873533. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIEMENS SIRECUST 1280, 1281 W/ARRHYTHMIA SOFTWARE?

SIEMENS SIRECUST 1280, 1281 W/ARRHYTHMIA SOFTWARE is a medical device that received FDA 510(k) clearance on 1988-01-29. The listed applicant is Medical Electronics Laboratories, Inc.. The 510(k) number is K873533.

When did SIEMENS SIRECUST 1280, 1281 W/ARRHYTHMIA SOFTWARE receive FDA 510(k) clearance?

SIEMENS SIRECUST 1280, 1281 W/ARRHYTHMIA SOFTWARE received FDA 510(k) clearance on 1988-01-29, under 510(k) number K873533.

Who is the listed applicant for SIEMENS SIRECUST 1280, 1281 W/ARRHYTHMIA SOFTWARE?

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 SIEMENS SIRECUST 1280, 1281 W/ARRHYTHMIA SOFTWARE?

The FDA product code for SIEMENS SIRECUST 1280, 1281 W/ARRHYTHMIA SOFTWARE is DSI.

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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.

K872249SIRECUST MODEL 960 AND 961 PATIENT MONITORING

Related Devices (Code: DSI)

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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