Device classification

Mattress, Water, Temperature Regulated

General Hospital · 21 CFR 880.5560

Class IProduct code FOHExempt
Open FDA's page for this record
Third party flag
N
Life sustain support flag
N
Gmp exempt flag
N
Summary malfunction reporting
Eligible
Product code
FOH
Review panel
HO
Medical specialty
HO
Device name
Mattress, Water, Temperature Regulated
Medical specialty description
General Hospital
Device class
1
Regulation number
880.5560
Implant flag
N
Submission type ID
4
Harmonized identifiers (openFDA)
K number
K812684, K872876, K812683, K812682, K954216, K812681
Registration number
3008058406, 3029871637, 3010617000, 3010409218, 3015526491, 3016507522
FEI number
3008058406, 3029871637, 3010409218, 3015526491, 3016507522, 3003793491
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.