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FDA 510(k)

OBSERVER * CENTRAL STATION

K-Number: K972498 · 1998-02-17

ApplicantJohnson & Johnson Medical, Inc.
Decision Date1998-02-17
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OBSERVER * CENTRAL STATION is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Medical, Inc.. It received FDA 510(k) clearance on 1998-02-17 under 510(k) number K972498. 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 OBSERVER * CENTRAL STATION?

OBSERVER * CENTRAL STATION is a medical device that received FDA 510(k) clearance on 1998-02-17. The listed applicant is Johnson & Johnson Medical, Inc.. The 510(k) number is K972498.

When did OBSERVER * CENTRAL STATION receive FDA 510(k) clearance?

OBSERVER * CENTRAL STATION received FDA 510(k) clearance on 1998-02-17, under 510(k) number K972498.

Who is the listed applicant for OBSERVER * CENTRAL STATION?

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

What is the FDA product code for OBSERVER * CENTRAL STATION?

The FDA product code for OBSERVER * CENTRAL STATION is 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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