Hannah Wireless Vital Signs Monitor
FDA 510(k) K991087 · Ilife Systems, Inc.
510(k) numberK991087
Submission
- Device name
- Hannah Wireless Vital Signs Monitor
- Applicant
- Ilife Systems, Inc.
Dallas, TX, US - Received
- March 31, 1999
- Decision date
- January 12, 2000
- Decision
- Substantially Equivalent - Subject to Tracking Reg. (ST)
- 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 |
| 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 |
| K810153 | Ventilatory Effort MonitorFLS · Traditional | Medicon, Inc. | 02/09/1981SE |
Questions and answers
When was Hannah Wireless Vital Signs Monitor cleared by the FDA?
Hannah Wireless Vital Signs Monitor (K991087) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on January 12, 2000, 287 days after the submission was received.
What is the product code of K991087?
The FDA product code is FLS – Monitor, Apnea, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.2377.