FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MOD. DM-357 BICARBONATE RETROFIT KIT
K Number: K800772
·
Decision May 14, 1980
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
11
Applicant Total
69
Review Days
37
Basic Information
- Device Name
- MOD. DM-357 BICARBONATE RETROFIT KIT
- K Number
- K800772
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
- Date Received
- April 7, 1980
- Decision Date
- May 14, 1980
- Product Code
- FKR
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FKR | Subsystem, Proportioning | FDA class 2 | Gastroenterology, Urology |
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|---|---|---|---|
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| K831423 | THERAPEUTIC EXCHANGE SYSTEM | Jan 3, 1984 | Substantially Equivalent |
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| K833476 | INTERSEPT 40 MICRON FILTER W/TUBING | Dec 27, 1983 | Substantially Equivalent |
| K833477 | INTERSEPT 40 MICRON FILTER | Dec 27, 1983 | Substantially Equivalent |
| K831424 | THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101 | Oct 14, 1983 | Substantially Equivalent |