Babytherm 8004 Babytherm 8010
FDA 510(k) K971198 · Drager, Inc.
510(k) numberK971198
Submission
- Device name
- Babytherm 8004 Babytherm 8010
- Applicant
- Drager, Inc.
Chantilly, VA, US - Received
- March 31, 1997
- Decision date
- October 3, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMT – Warmer, Infant Radiant
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5130
- Specialty
- General Hospital
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Questions and answers
When was Babytherm 8004 Babytherm 8010 cleared by the FDA?
Babytherm 8004 Babytherm 8010 (K971198) received a 510(k) decision of Substantially Equivalent on October 3, 1997, 186 days after the submission was received.
What is the product code of K971198?
The FDA product code is FMT – Warmer, Infant Radiant, a Class II (moderate risk) device regulated under 21 CFR 880.5130.