Revised Battery Charger
FDA 510(k) K790689 · Vickers America Medical Corp.
510(k) numberK790689
Submission
- Device name
- Revised Battery Charger
- Applicant
- Vickers America Medical Corp.
Mchenry, IL, US - Received
- April 10, 1979
- Decision date
- May 29, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FPL – Incubator, Neonatal Transport
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5410
- Specialty
- General Hospital
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Questions and answers
When was Revised Battery Charger cleared by the FDA?
Revised Battery Charger (K790689) received a 510(k) decision of Substantially Equivalent on May 29, 1979, 49 days after the submission was received.
What is the product code of K790689?
The FDA product code is FPL – Incubator, Neonatal Transport, a Class II (moderate risk) device regulated under 21 CFR 880.5410.