Babytherm 8000 LDR
FDA 510(k) K980886 · Draeger Medical, Inc.
510(k) numberK980886
Submission
- Device name
- Babytherm 8000 LDR
- Applicant
- Draeger Medical, Inc.
Telford, PA, US - Received
- March 9, 1998
- Decision date
- May 29, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMZ – Incubator, Neonatal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5400
- Specialty
- General Hospital
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Questions and answers
When was Babytherm 8000 LDR cleared by the FDA?
Babytherm 8000 LDR (K980886) received a 510(k) decision of Substantially Equivalent on May 29, 1998, 81 days after the submission was received.
What is the product code of K980886?
The FDA product code is FMZ – Incubator, Neonatal, a Class II (moderate risk) device regulated under 21 CFR 880.5400.