510(k) K080704
- Device
- LOW FLUID ALARM
- Applicant
- EM-TEC GMBH
- 510(k) number
- K080704
- Product code
- FLN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-04-17
- Date received
- 2008-03-12
- Regulation
- 880.2420
- Classification name
- Monitor, Electric For Gravity Flow Infusion Systems
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Statement
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- BERNHARD BRAND
- Address
- Lerchenberg 20 Finning, Bavaria DE 86923 86923
FDA Registration Numbers#
- 1643264
- 3003604053
- 2030624
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FLN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K172242 | DripAssist Plus | Shift Labs, Inc. | 2018-05-25 |
| K150687 | DripAssist | Shift Labs | 2015-10-13 |
| K133870 | FLUID LEVEL MONITOR | Coleman Laboratories | 2014-04-24 |
| K050783 | ISSYS DRUG FLOW MONITOR | Integrated Sensing Systems, Inc. | 2006-02-22 |
| K060123 | LEVELERT II FLUID LEVEL SENSOR | Smith & Nephew, Inc. | 2006-02-14 |
| K030136 | DRIP ALERT | Drip Alert, Inc. | 2003-04-07 |
| K022248 | STRYKER L3 HYDROLERT | Stryker Endoscopy | 2002-08-06 |
| K013121 | MT ALERT INFUSION MONITOR | Sierra Biosearch, Inc. | 2001-10-15 |
| K973025 | FLUID CENTURION (4-100-00) | Northgate Technologies, Inc. | 1997-11-20 |
| K972084 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M212 | Alexander Mfg. Co. | 1997-07-03 |
| K923561 | AC-901 I.V. INFUSION DROP COUNTER | Lamtic, Inc. | 1993-05-26 |
| K910323 | BEDSIDE FLUID MANAGEMENT SYSTEM 1000 (FMS-1000) | Uab Research Foundation | 1991-10-03 |
| K902808 | DRIPTROL | Trans-Pacific Healthcare-USA | 1990-10-01 |
| K903193 | SMITH & NEPHEW DYONICS LEVELERT SYSTEM | Smith & Nephew Dyonics, Inc. | 1990-08-30 |
| K893693 | H.U. I.V. DROP COUNTER | Li-Lien Corp. | 1989-10-27 |
Legacy Summary#
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FDA Review#
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