FLN — Monitor, Electric For Gravity Flow Infusion Systems Class II
FDA Device Classification
Classification Details
- Product Code
- FLN
- Device Class
- Class II
- Regulation Number
- 880.2420
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K172242 | shift labs | DripAssist Plus | May 25, 2018 |
| K150687 | shift labs | DripAssist | October 13, 2015 |
| K133870 | coleman laboratories | FLUID LEVEL MONITOR | April 24, 2014 |
| K080704 | em-tec | LOW FLUID ALARM | April 17, 2008 |
| K050783 | integrated sensing systems | ISSYS DRUG FLOW MONITOR | February 22, 2006 |
| K060123 | smith and nephew | LEVELERT II FLUID LEVEL SENSOR | February 14, 2006 |
| K030136 | drip alert | DRIP ALERT | April 7, 2003 |
| K022248 | stryker endoscopy | STRYKER L3 HYDROLERT | August 6, 2002 |
| K013121 | sierra biosearch | MT ALERT INFUSION MONITOR | October 15, 2001 |
| K973025 | northgate technologies | FLUID CENTURION (4-100-00) | November 20, 1997 |
| K972084 | alexander mfg | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M212 | July 3, 1997 |
| K923561 | lamtic | AC-901 I.V. INFUSION DROP COUNTER | May 26, 1993 |
| K910323 | uab research foundation | BEDSIDE FLUID MANAGEMENT SYSTEM 1000 (FMS-1000) | October 3, 1991 |
| K902808 | trans-pacific healthcare-usa | DRIPTROL | October 1, 1990 |
| K903193 | smith and nephew dyonics | SMITH & NEPHEW DYONICS LEVELERT SYSTEM | August 30, 1990 |
| K893693 | li-lien | H.U. I.V. DROP COUNTER | October 27, 1989 |
| K853843 | medtech intl | IV MATE | January 9, 1986 |
| K853549 | american mcgaw | MCGAW/DROP WATCH FLOW MONITOR | November 12, 1985 |
| K852433 | medix medical electronics (u.s.a.) | INFUSAFE 205 CATOLOG NO. 205.000 | June 27, 1985 |
| K850710 | travenol laboratories | TRAVENOL FLO-GARD 500 IV MONITOR | April 4, 1985 |