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FDA 510(k)

MONITOR, CARDIAC, W/BLOOD PRESS.&TEMP

K-Number: K772334 · 1978-02-21

ApplicantTelectronics, Inc.
Decision Date1978-02-21
Product CodeDSK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MONITOR, CARDIAC, W/BLOOD PRESS.&TEMP is the device name listed in this FDA 510(k) record. The listed applicant is Telectronics, Inc.. It received FDA 510(k) clearance on 1978-02-21 under 510(k) number K772334. The device is classified under product code DSK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONITOR, CARDIAC, W/BLOOD PRESS.&TEMP?

MONITOR, CARDIAC, W/BLOOD PRESS.&TEMP is a medical device that received FDA 510(k) clearance on 1978-02-21. The listed applicant is Telectronics, Inc.. The 510(k) number is K772334.

When did MONITOR, CARDIAC, W/BLOOD PRESS.&TEMP receive FDA 510(k) clearance?

MONITOR, CARDIAC, W/BLOOD PRESS.&TEMP received FDA 510(k) clearance on 1978-02-21, under 510(k) number K772334.

Who is the listed applicant for MONITOR, CARDIAC, W/BLOOD PRESS.&TEMP?

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

What is the FDA product code for MONITOR, CARDIAC, W/BLOOD PRESS.&TEMP?

The FDA product code for MONITOR, CARDIAC, W/BLOOD PRESS.&TEMP is DSK.

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Other records listing Telectronics, Inc. as applicant

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Related Devices (Code: DSK)

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.

K231586Endophys Blood Pressure Monitor model BPM-30Endophys Technologies, LLCK160945Endophys Blood Pressure MonitorEndophys Holdings, LLCK080670MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEMAtcor MedicalK070795SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEMAtcor Medical Pty, Ltd.K033738MONITORING SYSTEM, MODEL ARGUS PB-2200Schiller AGK021517ABP FOR WINDOWSRozinn Electronics, Inc.

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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