FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EMERSON MODEL 3MV-AP AND 3V-AP PRESS-
K Number: K832271
·
Decision Sep 12, 1983
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
77
Applicant Total
25
Review Days
62
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Basic Information
- Device Name
- EMERSON MODEL 3MV-AP AND 3V-AP PRESS-
- K Number
- K832271
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2600
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- J. H. Emerson Co.
- Date Received
- July 12, 1983
- Decision Date
- September 12, 1983
- Product Code
- CAP
- 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 |
|---|---|---|---|
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | FDA class 2 | Anesthesiology |
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Other Clearances by J. H. Emerson Co.
| K Number | Device Name | ||
|---|---|---|---|
| K002598 | EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MANUAL TIMING | Nov 22, 2000 | Substantially Equivalent |
| 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 |