510(k) K812177
- Device
- LIFE-TECH #1857 PRESSURE/POLOT MODULE
- Applicant
- LIFE-TECH INSTRUMENTS, INC.
- 510(k) number
- K812177
- Product code
- EXQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-09-09
- Date received
- 1981-08-03
- Regulation
- 876.1620
- Classification name
- Cystometer, Electrical Recording
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 9611102
- 3012174468
- 3011790297
- 9611896
- 3029753827
- 3004967767
- 3002806603
- 3034397200
- 3014929383
- 1223851
- 3015447513
- 3034424132
- 3017448360
- 3018383108
- 3003631667
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EXQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253537 | Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)); Glean Urodynamics System Abdominal Sensor (GUS-1000-A) | Bright Uro, Inc. | 2026-04-16 |
| K243052 | Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)) | Bright Uro, Inc. | 2025-03-24 |
| K931282 | VOLUME TRANSDUCER | Life-Tech Intl., Inc. | 1993-09-17 |
| K931574 | ADVANCE MODEL UDS-ADV | Laborie Medical Technologies, Ltd. | 1993-08-05 |
| K920574 | CAMSYS 6300 | F.M. Wiest USA, Inc. | 1993-02-17 |
| K880391 | DACOMED CYSTOMETER | Dacomed Corp. | 1988-04-27 |
| K781032 | AQUA-GEL | Murray, Salk, Inc. | 1978-12-15 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases