FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EMERSON MODEL 3MV-OAA ALARM MODULE
K Number: K854799
·
Decision Dec 11, 1985
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
119
Applicant Total
25
Review Days
9
Basic Information
- Device Name
- EMERSON MODEL 3MV-OAA ALARM MODULE
- K Number
- K854799
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1720
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- J. H. EMERSON CO.
- Date Received
- December 2, 1985
- Decision Date
- December 11, 1985
- Product Code
- CCL
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | FDA class 2 | Anesthesiology |
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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 |
| K872936 | 97-D EMERSON DIMMER CONTROL | Sep 24, 1987 | Substantially Equivalent |
| K872937 | 97-TD EMERSON TIMER/DIMMER CONTROL | Sep 24, 1987 | Substantially Equivalent |
| K864379 | EMERSON 3MV VOLUME VENTILATOR | Dec 15, 1986 | Substantially Equivalent |