FDA 510(k)

ECG PATIENT MONITOR 301

K-Number: K850156 · 1985-03-01

ApplicantRigel Medical Electronics, Inc.

Decision Date1985-03-01

Product CodeDRT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ECG PATIENT MONITOR 301 is the device name listed in this FDA 510(k) record. The listed applicant is Rigel Medical Electronics, Inc.. It received FDA 510(k) clearance on 1985-03-01 under 510(k) number K850156. 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 ECG PATIENT MONITOR 301?

ECG PATIENT MONITOR 301 is a medical device that received FDA 510(k) clearance on 1985-03-01. The listed applicant is Rigel Medical Electronics, Inc.. The 510(k) number is K850156.

When did ECG PATIENT MONITOR 301 receive FDA 510(k) clearance?

ECG PATIENT MONITOR 301 received FDA 510(k) clearance on 1985-03-01, under 510(k) number K850156.

Who is the listed applicant for ECG PATIENT MONITOR 301?

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

What is the FDA product code for ECG PATIENT MONITOR 301?

The FDA product code for ECG PATIENT MONITOR 301 is DRT.

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Other records listing Rigel Medical Electronics, Inc. as applicant

K884645PATIENT MONITOR RIGEL MODEL MULTICARE 429 K875160RIGEL MODEL MULTICARE 409 K850407NEONATAL MONITOR 309 K850155ECG PATIENT MONITOR 302 K843376ECG PATIENT MONITOR

Related Devices (Code: DRT)

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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.