510(k) K951442
- Device
- FLOLAB
- Applicant
- SYNECTICS MEDICAL, INC.
- 510(k) number
- K951442
- Product code
- EXY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-08-24
- Date received
- 1995-03-29
- Regulation
- 876.1800
- Classification name
- Uroflowmeter
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANNA PETTERSSON
- Address
- Renstienas Gata 12, 5tr. S-116 28 Stockholm SE S-11628 S-11628
FDA Registration Numbers#
- 1223851
- 3034424132
- 3029753827
- 3014644251
- 3013885240
- 3005515211
- 9611102
- 9613418
- 3016248661
- 3008959444
- 3034630389
- 3011707784
- 3017589456
- 3030516433
- 1224842
- 3017448360
- 3012174468
- 3014637079
- 3005862693
- 3014929383
- 3017845305
- 9611590
- 3031976597
- 3017726824
- 3007611554
- 3020978007
- 3005987240
- 3022472
- 3034397200
- 3003537036
- 2243374
- 3016096130
- 3006418479
- 3034693330
- 3009746061
- 3002807616
- 3030244515
- 3021192255
- 8030124
- 3021350028
- 3013683058
- 3015337348
- 3011383638
Source Documents#
Other 510(k) Records For Product Code EXY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K142425 | Uroflowmeter | Be Technologies, Inc. | 2014-10-27 |
| K022721 | UROPOWER | W.O.M. World of Medicine AG | 2003-08-26 |
| K971913 | GR100F URINE FLOWMETER | Albyn Medical , Ltd. | 1997-09-19 |
| K953999 | DANTEC DA CAPO | Dantec Medical, Inc. | 1995-11-21 |
| K944972 | URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRY | Myo/Kinetic Systems, Inc. | 1995-03-08 |
| K945495 | 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION | Fiberoptic Sensor Technlogies, Inc. | 1995-02-09 |
| K941105 | UORCAP,MODEL NUMBER UDS-UCAP | Laborie Medical Tech, Inc. | 1994-05-10 |
| K904557 | MICROFLO | Life-Tech Intl., Inc. | 1990-12-28 |
| K902408 | DIAGNOSTIC ULTRASOUND UFS 1005 | Diagnostic Ultrasound Corp. | 1990-08-10 |
| K900770 | HOME URODATA SYSTEM(TM) | Biodan Medical Systems, Ltd. | 1990-06-08 |
| K894968 | ULTRACOMPACT | Eutectic Electronics, Inc. | 1989-11-08 |
| K880504 | MCT MEDICAL BROWNE UROSCAN URODYNAMIC | Mct Medical, Inc. | 1988-06-17 |
| K873695 | MODEL 1859 TUMI/PRESSURE MODULE | Life-Tech Intl., Inc. | 1988-01-27 |
| K872077 | MODEL 1858 CAVRO/PRESSURE MODULE | Life-Tech Intl., Inc. | 1987-08-27 |
| K770897 | URODYNAMIC INSTRUMENTS | Life-Tech Instruments, Inc. | 1977-06-03 |
Legacy Summary#
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FDA Review#
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