Life-Tech #1857 Pressure/Polot Module
FDA 510(k) K812177 · Life-Tech Instruments, Inc.
510(k) numberK812177
Submission
- Device name
- Life-Tech #1857 Pressure/Polot Module
- Applicant
- Life-Tech Instruments, Inc.
Mchenry, IL, US - Received
- August 3, 1981
- Decision date
- September 9, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EXQ – Cystometer, Electrical Recording
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1620
- Specialty
- Gastroenterology, Urology
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|---|---|---|---|
| K253537 | Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System…EXQ · Traditional | Bright Uro, Inc. | 04/16/2026SE |
| K243052 | Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System…EXQ · Traditional | Bright Uro, Inc. | 03/24/2025SE |
| K931282 | Volume TransducerEXQ · Traditional | Life-Tech Intl., Inc. | 09/17/1993SE |
| K931574 | Advance Model Uds-AdvEXQ · Traditional | Laborie Medical Technologies, Ltd. | 08/05/1993SE |
| K920574 | Camsys 6300EXQ · Traditional | F.M. Wiest USA, Inc. | 02/17/1993SE |
| K880391 | Dacomed CystometerEXQ · Traditional | Dacomed Corp. | 04/27/1988SE |
| K781032 | Aqua-GelEXQ · Traditional | Murray, Salk, Inc. | 12/15/1978SE |
More from Murray, Salk, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K812179 | Life-Tech #1753 Biofeedback TrainerHCC · Traditional | 08/25/1981SE |
| K812180 | Life-Tech #5102 VisulabGWN · Traditional | 08/21/1981SE |
| K812178 | Life-Tech #'S 1106/1156 UrolabsFAP · Traditional | 08/13/1981SE |
| K800112 | Amblyopia TrainerHPL · Traditional | 03/10/1980SE |
| K790663 | Model 1750 Standing UrinalFFG · Traditional | 04/24/1979SE |
| K790664 | Model 1309 Audio MonitorIKN · Traditional | 04/23/1979SE |
| K781476 | Mular Gold Leaf Electrode Model 7501HLZ · Traditional | 11/15/1978SE |
| K781461 | Model 7320 Visual StimulatorGWE · Traditional | 11/08/1978SE |
| K781475 | Electrode Impedance Tester-Model 500GYA · Traditional | 09/07/1978SE |
| K781474 | Preamplifier Models 8101PI & 8102PIEWO · Traditional | 09/07/1978SE |
Questions and answers
When was Life-Tech #1857 Pressure/Polot Module cleared by the FDA?
Life-Tech #1857 Pressure/Polot Module (K812177) received a 510(k) decision of Substantially Equivalent on September 9, 1981, 37 days after the submission was received.
What is the product code of K812177?
The FDA product code is EXQ – Cystometer, Electrical Recording, a Class II (moderate risk) device regulated under 21 CFR 876.1620.