Infusion Controller, Parenteral
FDA 510(k) K781216 · National Patent Development Corp.
510(k) numberK781216
Submission
- Device name
- Infusion Controller, Parenteral
- Applicant
- National Patent Development Corp.
Mchenry, IL, US - Received
- July 17, 1978
- Decision date
- August 10, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FLS – Monitor, Apnea, Facility Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2377
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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|---|---|---|---|
| K011597 | Smartmonitor 2, Model 4000FLS · Abbreviated | Respironics Georgia, Inc. | 01/11/2002SE |
| K991087 | Hannah Wireless Vital Signs MonitorFLS · Traditional | Ilife Systems, Inc. | 01/12/2000ST |
| K962865 | Rembrandt SystemFLS · Traditional | Airsep Corp. | 10/25/1996ST |
| K951246 | Propaq Encore 200 Series Monitor with Neonatal Mode and Impedance Pneumography OptionsFLS · Traditional | Protocol Systems, Inc. | 02/02/1996ST |
| K894973 | Respitrace PlusFLS · Traditional | Hogan & Hartson | 10/30/1989SE |
| K832999 | Respiration MonitorFLS · Traditional | Litton Medical Electronics | 02/13/1984SE |
| K830778 | Monitoring Kit AMK-1FLS · Traditional | Alternative Design Systems, Inc. | 10/14/1983SE |
| K822077 | Respiration Monitor Type MR-10FLS · Traditional | New Dimensions IN Medicine, Inc. | 10/06/1982SE |
| K821721 | Clinical Data Apnea DetectorFLS · Traditional | Clinical Data, Inc. | 07/13/1982SE |
| K820943 | System I Infant Monitoring SysFLS · Traditional | Burr Engineering & Development Co. | 05/03/1982SE |
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| K822793 | Pio Root Canal IndicatorEIL · Traditional | 10/22/1982SE |
| K820028 | Zeon Composite Resin Light Cure SysEBF · Traditional | 03/11/1982SE |
| K820006 | Zeon Composite Resin SystemEBF · Traditional | 01/22/1982SE |
| K811446 | Hydron Wound Dressing KitKMF · Traditional | 06/12/1981SE |
| K801484 | Root Canal Filling Applicator NeedlesEIC · Traditional | 07/21/1980SE |
| K801483 | Mark IV SyringeEIC · Traditional | 07/21/1980SE |
| K801482 | Hydron Root Canal Filling MaterialKIF · Traditional | 07/21/1980SE |
| K792136 | Hypo-Allergenic Plastic TapeFPX · Traditional | 01/16/1980SE |
Questions and answers
When was Infusion Controller, Parenteral cleared by the FDA?
Infusion Controller, Parenteral (K781216) received a 510(k) decision of Substantially Equivalent on August 10, 1978, 24 days after the submission was received.
What is the product code of K781216?
The FDA product code is FLS – Monitor, Apnea, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.2377.