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FDA 510(k)

BABYLOG 8000 PLUS

K-Number: K974176 · 1998-06-17

ApplicantDrager, Inc.
Decision Date1998-06-17
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BABYLOG 8000 PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Drager, Inc.. It received FDA 510(k) clearance on 1998-06-17 under 510(k) number K974176. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BABYLOG 8000 PLUS?

BABYLOG 8000 PLUS is a medical device that received FDA 510(k) clearance on 1998-06-17. The listed applicant is Drager, Inc.. The 510(k) number is K974176.

When did BABYLOG 8000 PLUS receive FDA 510(k) clearance?

BABYLOG 8000 PLUS received FDA 510(k) clearance on 1998-06-17, under 510(k) number K974176.

Who is the listed applicant for BABYLOG 8000 PLUS?

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

What is the FDA product code for BABYLOG 8000 PLUS?

The FDA product code for BABYLOG 8000 PLUS is CBK.

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Related Devices (Code: CBK)

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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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