Fluid Centurion (4-100-00)
FDA 510(k) K973025 · Northgate Technologies, Inc.
510(k) numberK973025
Submission
- Device name
- Fluid Centurion (4-100-00)
- Applicant
- Northgate Technologies, Inc.
Elgin, IL, US - Received
- August 14, 1997
- Decision date
- November 20, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FLN – Monitor, Electric For Gravity Flow Infusion Systems
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2420
- Specialty
- General Hospital
Other 510(k)s with product code FLN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K172242 | DripAssist PlusFLN · Traditional | Shift Labs, Inc. | 05/25/2018SE |
| K150687 | DripAssistFLN · Traditional | Shift Labs | 10/13/2015SE |
| K133870 | Fluid Level MonitorFLN · Traditional | Coleman Laboratories | 04/24/2014SE |
| K080704 | Low Fluid AlarmFLN · Abbreviated | Em-Tec GmbH | 04/17/2008SE |
| K050783 | Issys Drug Flow MonitorFLN · Traditional | Integrated Sensing Systems, Inc. | 02/22/2006SE |
| K060123 | Levelert II Fluid Level SensorFLN · Special | Smith & Nephew, Inc. | 02/14/2006SE |
| K030136 | Drip AlertFLN · Traditional | Drip Alert, Inc. | 04/07/2003SE |
| K022248 | Stryker L3 HydrolertFLN · Traditional | Stryker Endoscopy | 08/06/2002SE |
| K013121 | MT Alert Infusion MonitorFLN · Traditional | Sierra Biosearch, Inc. | 10/15/2001SE |
| K972084 | Alexander Manufacturing Co. Rechargeable Battery Part Number M212FLN · Traditional | Alexander Mfg. Co. | 07/03/1997SE |
More from Alexander Mfg. Co.
| 510(k) | Device | Decision |
|---|---|---|
| K202813 | URO-TOUCH 9 French ProbeFFK · Traditional | 06/14/2021SE |
| K202944 | NEBULAE SRS Laparoscopic Surgical Smoke Removal SystemFYD · Traditional | 03/25/2021SE |
| K130368 | Autolith Touch; Uro TouchFFK · Traditional | 11/15/2013SE |
| K120151 | Nebulae IHIF · Traditional | 08/17/2012SE |
| K041560 | Flo-AssistantHIF · Traditional | 09/28/2004SE |
| K033614 | Mistic Humidification System 850-00/01/02, 2215HIF · Traditional | 07/29/2004SE |
| K022052 | 40LPM Abdominal Insufflator, Catalog # 72-00203-0HIF · Traditional | 01/24/2003SE |
| K010053 | Humi-Flow, Model 6-850-00/ 01/02HIF · Traditional | 10/23/2001SE |
| K011928 | Hydrotower Arthroscopic Administration Tubing Set, Model 7-460-05FPA · Traditional | 08/10/2001SE |
| K001325 | Flo Assistant, Model 4-250-00LJH · Traditional | 08/18/2000SE |
Questions and answers
When was Fluid Centurion (4-100-00) cleared by the FDA?
Fluid Centurion (4-100-00) (K973025) received a 510(k) decision of Substantially Equivalent on November 20, 1997, 98 days after the submission was received.
What is the product code of K973025?
The FDA product code is FLN – Monitor, Electric For Gravity Flow Infusion Systems, a Class II (moderate risk) device regulated under 21 CFR 880.2420.