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FDA 510(k)

AMBULATORY BLOOD PRESSURE MONITOR, MDL# 5100-01

K-Number: K925899 · 1993-05-21

ApplicantWelch Allyn, Inc.
Decision Date1993-05-21
Product CodeDSK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AMBULATORY BLOOD PRESSURE MONITOR, MDL# 5100-01 is the device name listed in this FDA 510(k) record. The listed applicant is Welch Allyn, Inc.. It received FDA 510(k) clearance on 1993-05-21 under 510(k) number K925899. 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 AMBULATORY BLOOD PRESSURE MONITOR, MDL# 5100-01?

AMBULATORY BLOOD PRESSURE MONITOR, MDL# 5100-01 is a medical device that received FDA 510(k) clearance on 1993-05-21. The listed applicant is Welch Allyn, Inc.. The 510(k) number is K925899.

When did AMBULATORY BLOOD PRESSURE MONITOR, MDL# 5100-01 receive FDA 510(k) clearance?

AMBULATORY BLOOD PRESSURE MONITOR, MDL# 5100-01 received FDA 510(k) clearance on 1993-05-21, under 510(k) number K925899.

Who is the listed applicant for AMBULATORY BLOOD PRESSURE MONITOR, MDL# 5100-01?

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

What is the FDA product code for AMBULATORY BLOOD PRESSURE MONITOR, MDL# 5100-01?

The FDA product code for AMBULATORY BLOOD PRESSURE MONITOR, MDL# 5100-01 is DSK.

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Other records listing Welch Allyn, 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.

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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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