Infussion Alarm System I.A.S. CAT.#1118
FDA 510(k) K802011 · Pollak (Intl.), Ltd.
510(k) numberK802011
Submission
- Device name
- Infussion Alarm System I.A.S. CAT.#1118
- Applicant
- Pollak (Intl.), Ltd.
Mchenry, IL, US - Received
- August 20, 1980
- Decision date
- October 31, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
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|---|---|---|---|
| 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 |
| K973025 | Fluid Centurion (4-100-00)FLN · Traditional | Northgate Technologies, Inc. | 11/20/1997SE |
More from Northgate Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K000227 | UmbicutHFW · Traditional | 04/27/2000SE |
| K810049 | Pedicat*KMJ · Traditional | 04/21/1981SE |
| K810050 | Vecafix*KGX · Traditional | 03/26/1981SE |
| K802009 | Flowclamp CAT.#1011 & 1012FKK · Traditional | 10/31/1980SE |
| K802017 | Dressing Change Set CAT.#910-930KDD · Traditional | 10/10/1980SE |
| K802007 | Pediwet=Guaze Impregnated with PetrolFRQ · Traditional | 09/26/1980SE |
| K802022 | Sterile Guaze Swabs CAT.#301-420EFQ · Traditional | 09/16/1980SE |
| K802021 | Pediband CAT.#195-197NAD · Traditional | 09/16/1980SE |
| K802019 | Suture Removal Set CAT.#906KDD · Traditional | 09/16/1980SE |
| K802016 | Eye Applicators CAT.#980-983KXF · Traditional | 09/16/1980SE |
Questions and answers
When was Infussion Alarm System I.A.S. CAT.#1118 cleared by the FDA?
Infussion Alarm System I.A.S. CAT.#1118 (K802011) received a 510(k) decision of Substantially Equivalent on October 31, 1980, 72 days after the submission was received.
What is the product code of K802011?
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.