Stryker L3 Hydrolert
FDA 510(k) K022248 · Stryker Endoscopy
510(k) numberK022248
Submission
- Device name
- Stryker L3 Hydrolert
- Applicant
- Stryker Endoscopy
San Jose, CA, US - Received
- July 12, 2002
- Decision date
- August 6, 2002
- 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
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| K080704 | Low Fluid AlarmFLN · Abbreviated | Em-Tec GmbH | 04/17/2008SE |
| K050783 | Issys Drug Flow MonitorFLN · Traditional | Integrated Sensing Systems, Inc. | 02/22/2006SE |
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| K030136 | Drip AlertFLN · Traditional | Drip Alert, Inc. | 04/07/2003SE |
| K013121 | MT Alert Infusion MonitorFLN · Traditional | Sierra Biosearch, Inc. | 10/15/2001SE |
| K973025 | Fluid Centurion (4-100-00)FLN · Traditional | Northgate Technologies, Inc. | 11/20/1997SE |
| K972084 | Alexander Manufacturing Co. Rechargeable Battery Part Number M212FLN · Traditional | Alexander Mfg. Co. | 07/03/1997SE |
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Questions and answers
When was Stryker L3 Hydrolert cleared by the FDA?
Stryker L3 Hydrolert (K022248) received a 510(k) decision of Substantially Equivalent on August 6, 2002, 25 days after the submission was received.
What is the product code of K022248?
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.