Respiration Monitor
FDA 510(k) K832999 · Litton Medical Electronics
510(k) numberK832999
Submission
- Device name
- Respiration Monitor
- Applicant
- Litton Medical Electronics
Mchenry, IL, US - Received
- August 18, 1983
- Decision date
- February 13, 1984
- 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
Other 510(k)s with product code FLS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| 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 |
| K810153 | Ventilatory Effort MonitorFLS · Traditional | Medicon, Inc. | 02/09/1981SE |
More from Medicon, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K840522 | Recomed Blood-Flow Meter H236-052-02DPW · Traditional | 05/16/1985SE |
| K840899 | Servomed Arrhycomp Central Monitor SysDSI · Traditional | 11/20/1984SE |
| K840439 | Recomed Cardiac Output Meter 236067-DXG · Traditional | 11/20/1984SE |
| K840523 | Servomed Pulse Amplifier MODULE-206-DRT · Traditional | 10/29/1984SE |
| K840524 | Servomed Basic Bedside Unit SMV 110TPDRT · Traditional | 10/26/1984SE |
| K840832 | Servomed Oxcardiore Spirograph 324/111DRT · Traditional | 09/20/1984SE |
| K840209 | Servomed Medivision Scope SMV-235DXJ · Traditional | 09/20/1984SE |
| K840525 | Servomed Compact Monitor SMK 155-1/101DRT · Traditional | 06/01/1984SE |
| K840521 | Servomed Digital Display ModuleDRT · Traditional | 06/01/1984SE |
| K834600 | Recomb ECG PREAMPLIFIER/206 069 03DRT · Traditional | 06/01/1984SE |
Questions and answers
When was Respiration Monitor cleared by the FDA?
Respiration Monitor (K832999) received a 510(k) decision of Substantially Equivalent on February 13, 1984, 179 days after the submission was received.
What is the product code of K832999?
The FDA product code is FLS – Monitor, Apnea, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.2377.