Peak Flow Rate Meter
FDA 510(k) K893827 · Laytech Medical Co.
510(k) numberK893827
Submission
- Device name
- Peak Flow Rate Meter
- Applicant
- Laytech Medical Co.
Arlington Heights, IL, US - Received
- May 24, 1989
- Decision date
- August 11, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FFG – Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1800
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FFG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K883274 | Surgitek (R) Uroflow SystemFFG · Traditional | Medical Engineering Corp. | 02/08/1989SE |
| K850169 | Eris Uro-Diagnostic SystemFFG · Traditional | Eris Medical Technology | 04/22/1985SE |
| K844338 | 1URO-LOG Home Diagnostic PackFFG · Traditional | Epcom Medical Systems, Inc. | 02/25/1985SE |
| K843442 | Urinary Drainage Container 2013 withFFG · Traditional | Vital Metrics, Inc. | 01/03/1985SE |
| K843441 | Urinary Drainage Container 2012-WITHFFG · Traditional | Vital Metrics, Inc. | 01/03/1985SE |
| K844030 | Accumeter Electronic Urinemeter SystemFFG · Traditional | Travenol Laboratories, S.A. | 11/20/1984SE |
| K843224 | Uropump Model 1711FFG · Traditional | Life-Tech Intl., Inc. | 10/19/1984SE |
| K833043 | UrometerFFG · Traditional | Browne Medical, Inc. | 02/04/1984SE |
| K813641 | Vital Metrics Urine Monitoring SystemFFG · Traditional | Vital Metrics, Inc. | 03/01/1982SE |
| K813082 | Ureofix 500 Urine Measuring SystemFFG · Traditional | Burron Medical Products, Inc. | 12/31/1981SE |
More from Burron Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K896581 | Pediatric Drain BagFFH · Traditional | 01/31/1990SE |
Questions and answers
When was Peak Flow Rate Meter cleared by the FDA?
Peak Flow Rate Meter (K893827) received a 510(k) decision of Substantially Equivalent on August 11, 1989, 79 days after the submission was received.
What is the product code of K893827?
The FDA product code is FFG – Device, Urine Flow Rate Measuring, Non-Electrical, Disposable, a Class II (moderate risk) device regulated under 21 CFR 876.1800.