FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WARMING LISTHTS #96H & 96HT
K Number: K812745
·
Decision Nov 2, 1981
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
91
Applicant Total
25
Review Days
34
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Basic Information
- Device Name
- WARMING LISTHTS #96H & 96HT
- K Number
- K812745
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5130
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- J. H. Emerson Co.
- Date Received
- September 29, 1981
- Decision Date
- November 2, 1981
- Product Code
- FMT
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FMT | Warmer, Infant Radiant | FDA class 2 | General Hospital |
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Other Clearances by J. H. Emerson Co.
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|---|---|---|---|
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| K920910 | OXYGEN POWERED RESUSCITATOR FOR CPR | Jan 12, 1993 | Substantially Equivalent |
| K924174 | EMERSON IN-EXSUFFLATOR, MODELS 2-CM & 2-CA | Nov 17, 1992 | Substantially Equivalent |
| K902764 | EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARM | Nov 19, 1990 | Substantially Equivalent |
| K896721 | MODEL 7-AT TREATMENT CHAMBER | Jan 22, 1990 | Substantially Equivalent |
| K881808 | EMERSON CHEST RESPIRATOR, MODEL 33-CRE | Aug 4, 1988 | Substantially Equivalent |
| K873489 | EMERSON DISPOS THORACIC DRAINAGE SET - 551-8000 | Dec 29, 1987 | Substantially Equivalent |
| K872937 | 97-TD EMERSON TIMER/DIMMER CONTROL | Sep 24, 1987 | Substantially Equivalent |
| K872936 | 97-D EMERSON DIMMER CONTROL | Sep 24, 1987 | Substantially Equivalent |
| K864379 | EMERSON 3MV VOLUME VENTILATOR | Dec 15, 1986 | Substantially Equivalent |