FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THORACIC DRAINAGE SET #55-DB2-G
K Number: K812746
·
Decision Oct 26, 1981
Classifications
1
FEI Numbers
276
Registration Numbers
276
Same Product Code
47
Applicant Total
25
Review Days
27
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Basic Information
- Device Name
- THORACIC DRAINAGE SET #55-DB2-G
- K Number
- K812746
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- J. H. Emerson Co.
- Date Received
- September 29, 1981
- Decision Date
- October 26, 1981
- Product Code
- KDQ
- 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 |
|---|---|---|---|
| KDQ | Bottle, Collection, Vacuum | FDA class 2 | General Hospital |
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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 |