FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANGIO-FLO MONITORING KIT
K Number: K801173
·
Decision May 28, 1980
Classifications
1
FEI Numbers
147
Registration Numbers
147
Same Product Code
174
Applicant Total
6
Review Days
12
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Basic Information
- Device Name
- ANGIO-FLO MONITORING KIT
- K Number
- K801173
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Hospital Products Co.
- Date Received
- May 16, 1980
- Decision Date
- May 28, 1980
- Product Code
- KRA
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| KRA | Catheter, Continuous Flush | FDA class 2 | Cardiovascular |
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Other Clearances by Hospital Products Co.
| K Number | Device Name | ||
|---|---|---|---|
| K823696 | MICRO Z BLOOD COLLECTING NEEDLES | Jan 26, 1983 | Substantially Equivalent |
| K810318 | PARKE-DAVIS NON-WOVEN SPONGE | Feb 26, 1981 | Substantially Equivalent |
| K801602 | DESERET I.V. FILTER | Aug 27, 1980 | Substantially Equivalent |
| K792386 | NUTRA-PH INSTRUMENT MILK | Dec 10, 1979 | Substantially Equivalent |
| K791350 | POPE AMBULATORY HALO VEST | Aug 3, 1979 | Substantially Equivalent |