Flolab
FDA 510(k) K951442 · Synectics Medical, Inc.
510(k) numberK951442
Submission
- Device name
- Flolab
- Applicant
- Synectics Medical, Inc.
S-116 28 Stockholm, SE - Received
- March 29, 1995
- Decision date
- August 24, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EXY – Uroflowmeter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1800
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code EXY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K142425 | UroflowmeterEXY · Traditional | Be Technologies, Inc. | 10/27/2014SE |
| K022721 | UropowerEXY · Traditional | W.O.M. World of Medicine AG | 08/26/2003SE |
| K971913 | GR100F Urine FlowmeterEXY · Traditional | Albyn Medical , Ltd. | 09/19/1997SE |
| K953999 | Dantec Da CapoEXY · Traditional | Dantec Medical, Inc. | 11/21/1995SE |
| 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 |
| K900770 | Home Urodata System(Tm)EXY · Traditional | Biodan Medical Systems, Ltd. | 06/08/1990SE |
More from Biodan Medical Systems, Ltd.
Questions and answers
When was Flolab cleared by the FDA?
Flolab (K951442) received a 510(k) decision of Substantially Equivalent on August 24, 1995, 148 days after the submission was received.
What is the product code of K951442?
The FDA product code is EXY – Uroflowmeter, a Class II (moderate risk) device regulated under 21 CFR 876.1800.