SMITH & NEPHEW DYONICS LEVELERT SYSTEM
FDA 510(k) clearance K903193 · decided 1990-08-30
Clearance details
- K-number
- K903193
- Device name
- SMITH & NEPHEW DYONICS LEVELERT SYSTEM
- Applicant
- Smith & Nephew Dyonics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-07-19
- Decision date
- 1990-08-30
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- FLN
- Device class
- 2
- Regulation number
- 880.2420
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Andover, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Smith & Nephew Dyonics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DripAssist Plus (K172242) | Shift Labs, Inc. | 2018-05-25 |
| DripAssist (K150687) | Shift Labs | 2015-10-13 |
| FLUID LEVEL MONITOR (K133870) | Coleman Laboratories | 2014-04-24 |
| LOW FLUID ALARM (K080704) | Em-Tec GmbH | 2008-04-17 |
| ISSYS DRUG FLOW MONITOR (K050783) | Integrated Sensing Systems, Inc. | 2006-02-22 |
| LEVELERT II FLUID LEVEL SENSOR (K060123) | Smith & Nephew, Inc. | 2006-02-14 |
| DRIP ALERT (K030136) | Drip Alert, Inc. | 2003-04-07 |
| STRYKER L3 HYDROLERT (K022248) | Stryker Endoscopy | 2002-08-06 |
| MT ALERT INFUSION MONITOR (K013121) | Sierra Biosearch, Inc. | 2001-10-15 |
| FLUID CENTURION (4-100-00) (K973025) | Northgate Technologies, Inc. | 1997-11-20 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M212 (K972084) | Alexander Mfg. Co. | 1997-07-03 |
| AC-901 I.V. INFUSION DROP COUNTER (K923561) | Lamtic, Inc. | 1993-05-26 |
Recalls involving this device
No recalls on record reference this clearance.