FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PRESSURE INFUSOR
K Number: K881977
·
Decision Jul 29, 1988
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
34
Applicant Total
14
Review Days
79
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Basic Information
- Device Name
- PRESSURE INFUSOR
- K Number
- K881977
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5420
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Primrose Medical, Inc.
- Date Received
- May 11, 1988
- Decision Date
- July 29, 1988
- Product Code
- KZD
- 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 |
|---|---|---|---|
| KZD | Infusor, Pressure, For I.V. Bags | FDA class 1 | General Hospital |
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Other Clearances by Primrose Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K884714 | BILIARY DIALATOR | Sep 29, 1989 | Substantially Equivalent |
| K884715 | ACHELASIA BALLOON DIALATOR | Sep 29, 1989 | Substantially Equivalent |
| K884713 | COLONIC BALLOON DIALATORS | Sep 29, 1989 | Substantially Equivalent |
| K884711 | URETHRAL AND URETERAL BALLOON DILATATORS | Sep 29, 1989 | Substantially Equivalent |
| K884709 | ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL) | Sep 8, 1989 | Substantially Equivalent |
| K884712 | ESOPHAGEAL AND PYLORIC BALLOON DIALATORS | Sep 8, 1989 | Substantially Equivalent |
| K883420 | LANCET, BLOOD | Aug 26, 1988 | Substantially Equivalent |
| K881976 | CATHETER, INTRAVASCULAR | Aug 4, 1988 | Substantially Equivalent |
| K881975 | SET, INTRAVASCULAR | Jul 29, 1988 | Substantially Equivalent |
| K881978 | ENTERAL FEEDING TUBES | Jul 13, 1988 | Substantially Equivalent |