Cleared Traditional

BABYTHERM 8000 LDR

K980886 · Draeger Medical, Inc. · General Hospital
May 1998
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K980886 is an FDA 510(k) clearance for the BABYTHERM 8000 LDR, a Incubator, Neonatal (Class II — Special Controls, product code FMZ), submitted by Draeger Medical, Inc. (Telford, US). The FDA issued a Cleared decision on May 29, 1998, 81 days after receiving the submission on March 9, 1998. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5400.

Submission Details

510(k) Number K980886 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 1998
Decision Date May 29, 1998
Days to Decision 81 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMZ — Incubator, Neonatal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5400

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