Volume Transducer
FDA 510(k) K931282 · Life-Tech Intl., Inc.
510(k) numberK931282
Submission
- Device name
- Volume Transducer
- Applicant
- Life-Tech Intl., Inc.
Houston, TX, US - Received
- March 12, 1993
- Decision date
- September 17, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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| K243052 | Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System…EXQ · Traditional | Bright Uro, Inc. | 03/24/2025SE |
| K931574 | Advance Model Uds-AdvEXQ · Traditional | Laborie Medical Technologies, Ltd. | 08/05/1993SE |
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| K880391 | Dacomed CystometerEXQ · Traditional | Dacomed Corp. | 04/27/1988SE |
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Questions and answers
When was Volume Transducer cleared by the FDA?
Volume Transducer (K931282) received a 510(k) decision of Substantially Equivalent on September 17, 1993, 189 days after the submission was received.
What is the product code of K931282?
The FDA product code is EXQ – Cystometer, Electrical Recording, a Class II (moderate risk) device regulated under 21 CFR 876.1620.