Respiration Monitor
FDA 510(k) K760104 · Air-Shields, Inc.
510(k) numberK760104
Submission
- Device name
- Respiration Monitor
- Applicant
- Air-Shields, Inc.
Mchenry, IL, US - Received
- June 23, 1976
- Decision date
- September 21, 1976
- 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
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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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| K971256 | Duo-Lite Phototherapy SystemLBI · Traditional | 09/24/1997SE |
| K960980 | Isolette Infant IncubatorFMZ · Traditional | 07/30/1996SE |
| K924709 | Satcare Oxygen Controller/Monitor W/ Pulse OximeteKLK · Traditional | 01/17/1996SE |
| K940951 | RW Resucitaire Infant Radiant WarmerFMT · Traditional | 05/03/1995SE |
| K940975 | C450/C400 Infant IncubatorsFMZ · Traditional | 06/23/1994SE |
| K941106 | Model TI500 Isolette Infant IncubatorFPL · Traditional | 06/10/1994SE |
| K924170 | Isolette Incubator Humidity MeterFMZ · Traditional | 02/05/1993SE |
| K922150 | Examination LampKZF · Traditional | 07/21/1992SE |
Questions and answers
When was Respiration Monitor cleared by the FDA?
Respiration Monitor (K760104) received a 510(k) decision of Substantially Equivalent on September 21, 1976, 90 days after the submission was received.
What is the product code of K760104?
The FDA product code is FLS – Monitor, Apnea, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.2377.