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FDA 510(k)

ENSEMBLE CENTRAL STATION MONITOR

K-Number: K970358 · 1998-02-11

ApplicantMennen Medical, Inc.
Decision Date1998-02-11
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ENSEMBLE CENTRAL STATION MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Mennen Medical, Inc.. It received FDA 510(k) clearance on 1998-02-11 under 510(k) number K970358. 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 ENSEMBLE CENTRAL STATION MONITOR?

ENSEMBLE CENTRAL STATION MONITOR is a medical device that received FDA 510(k) clearance on 1998-02-11. The listed applicant is Mennen Medical, Inc.. The 510(k) number is K970358.

When did ENSEMBLE CENTRAL STATION MONITOR receive FDA 510(k) clearance?

ENSEMBLE CENTRAL STATION MONITOR received FDA 510(k) clearance on 1998-02-11, under 510(k) number K970358.

Who is the listed applicant for ENSEMBLE CENTRAL STATION MONITOR?

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

What is the FDA product code for ENSEMBLE CENTRAL STATION MONITOR?

The FDA product code for ENSEMBLE CENTRAL STATION MONITOR is DSI.

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Other records listing Mennen Medical, 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.

K030722ENVOY PATIENT MONITORK983864ETCO2 VITAL SIGNS MODULEK991775MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WSK982697MODIFICATION TO ENSEMBLE CENTRAL STATION MONITORK974510ENVOY PATIENT MONITORK940081MERCURY

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Related Devices (Code: DSI)

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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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