510(k) K771655
- Device
- CURITY PEAKOMETER
- Applicant
- Kendall Research Center
- 510(k) number
- K771655
- Product code
- FFG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-10-14
- Date received
- 1977-08-29
- Regulation
- 876.1800
- Classification name
- Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3010339057
- 3016884033
- 3006673317
- 1018233
- 3007007790
- 3009104075
- 3012568936
- 3011987967
- 9612030
- 3005669815
- 1928237
- 3003528228
- 3008388005
- 3005515211
- 3008806809
- 3011707784
- 1420054
- 3010131137
- 3015173212
- 9611590
- 2032112
- 3006542380
- 3016758972
- 2030624
- 1423537
- 3006082230
- 3015058854
- 3013530405
- 3004122598
- 3018116884
- 2029015
- 3016685983
- 3033796870
- 3016171914
- 3008496560
- 3031184338
- 9616991
- 1921846
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FFG#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K893827 | PEAK FLOW RATE METER | Laytech Medical Co. | 1989-08-11 |
| K883274 | SURGITEK (R) UROFLOW SYSTEM | Medical Engineering Corp. | 1989-02-08 |
| K850169 | ERIS URO-DIAGNOSTIC SYSTEM | Eris Medical Technology | 1985-04-22 |
| K844338 | 1URO-LOG HOME DIAGNOSTIC PACK | Epcom Medical Systems, Inc. | 1985-02-25 |
| K843442 | URINARY DRAINAGE CONTAINER 2013 WITH | Vital Metrics, Inc. | 1985-01-03 |
| K843441 | URINARY DRAINAGE CONTAINER 2012-WITH | Vital Metrics, Inc. | 1985-01-03 |
| K844030 | ACCUMETER ELECTRONIC URINEMETER SYSTEM | Travenol Laboratories, S.A. | 1984-11-20 |
| K843224 | UROPUMP MODEL 1711 | Life-Tech Intl., Inc. | 1984-10-19 |
| K833043 | UROMETER | Browne Medical, Inc. | 1984-02-04 |
| K813641 | VITAL METRICS URINE MONITORING SYSTEM | Vital Metrics, Inc. | 1982-03-01 |
| K813082 | UREOFIX 500 URINE MEASURING SYSTEM | Burron Medical Products, Inc. | 1981-12-31 |
| K811925 | UROFLOWMETER | C.R. Bard, Inc. | 1981-09-08 |
| K790894 | URITRON URINE METER | Joseph F. Daniel, C.R.N.A. | 1979-09-07 |
| K790365 | FLUID MEASUREMENT STAND | Hewlett-Packard Co. | 1979-05-11 |
| K790663 | MODEL 1750 STANDING URINAL | Life-Tech Instruments, Inc. | 1979-04-24 |