Model 1859 Tumi/Pressure Module
FDA 510(k) K873695 · Life-Tech Intl., Inc.
510(k) numberK873695
Submission
- Device name
- Model 1859 Tumi/Pressure Module
- Applicant
- Life-Tech Intl., Inc.
Houston, TX, US - Received
- September 14, 1987
- Decision date
- January 27, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EXY – Uroflowmeter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1800
- Specialty
- Gastroenterology, Urology
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|---|---|---|---|
| K142425 | UroflowmeterEXY · Traditional | Be Technologies, Inc. | 10/27/2014SE |
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| K971913 | GR100F Urine FlowmeterEXY · Traditional | Albyn Medical , Ltd. | 09/19/1997SE |
| K953999 | Dantec Da CapoEXY · Traditional | Dantec Medical, Inc. | 11/21/1995SE |
| K951442 | FlolabEXY · Traditional | Synectics Medical, Inc. | 08/24/1995SE |
| K944972 | Uro-Gram Cystomrtrogram with UroflowmetryEXY · Traditional | Myo/Kinetic Systems, Inc. | 03/08/1995SE |
| K945495 | 4-CHANNEL Urodynamic Monitor with Uro-Flo OptionEXY · Traditional | Fiberoptic Sensor Technlogies, Inc. | 02/09/1995SE |
| K941105 | Uorcap,Model Number Uds-UcapEXY · Traditional | Laborie Medical Tech, Inc. | 05/10/1994SE |
| K904557 | MicrofloEXY · Traditional | Life-Tech Intl., Inc. | 12/28/1990SE |
| K902408 | Diagnostic Ultrasound Ufs 1005EXY · Traditional | Diagnostic Ultrasound Corp. | 08/10/1990SE |
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Questions and answers
When was Model 1859 Tumi/Pressure Module cleared by the FDA?
Model 1859 Tumi/Pressure Module (K873695) received a 510(k) decision of Substantially Equivalent on January 27, 1988, 135 days after the submission was received.
What is the product code of K873695?
The FDA product code is EXY – Uroflowmeter, a Class II (moderate risk) device regulated under 21 CFR 876.1800.