P. Urine Meter, 250CC
FDA 510(k) K872824 · Ni-Med, Inc.
510(k) numberK872824
Submission
- Device name
- P. Urine Meter, 250CC
- Applicant
- Ni-Med, Inc.
South Lyon, MI, US - Received
- July 16, 1987
- Decision date
- October 14, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KNX – Collector, Urine, (And Accessories) For Indwelling Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5250
- Specialty
- Gastroenterology, Urology
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| K971764 | Welcon Hue-Vu Urinary Drainage BagKNX · Traditional | Welcon, Inc. | 07/29/1997SE |
| K964690 | Liberty ValveKNX · Traditional | Cleveland Medical Devices, Inc. | 03/21/1997SE |
| K964745 | Amsino Urinary Drainage BagKNX · Traditional | Amsino Intl., Inc. | 03/18/1997SE |
| K962652 | Urinary Drainage Bag, (Reorder No. 0749 - Product No. 900-749)KNX · Traditional | Customed, Inc. | 10/04/1996SE |
| K960949 | Prosys Bedside Drainage Bag (Sterile) Model 650167KNX · Traditional | Bristol-Myers Squibb | 04/19/1996SE |
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Questions and answers
When was P. Urine Meter, 250CC cleared by the FDA?
P. Urine Meter, 250CC (K872824) received a 510(k) decision of Substantially Equivalent on October 14, 1987, 90 days after the submission was received.
What is the product code of K872824?
The FDA product code is KNX – Collector, Urine, (And Accessories) For Indwelling Catheter, a Class II (moderate risk) device regulated under 21 CFR 876.5250.