510(k) K830778
- Device
- MONITORING KIT AMK-1
- Applicant
- ALTERNATIVE DESIGN SYSTEMS, INC.
- 510(k) number
- K830778
- Product code
- FLS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-10-14
- Date received
- 1983-03-11
- Regulation
- 868.2377
- Classification name
- Monitor, Apnea, Facility Use
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3009973336
- 3006182632
- 3005783425
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FLS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K011597 | SMARTMONITOR 2, MODEL 4000 | Respironics Georgia, Inc. | 2002-01-11 |
| K991087 | HANNAH WIRELESS VITAL SIGNS MONITOR | Ilife Systems, Inc. | 2000-01-12 |
| K962865 | REMBRANDT SYSTEM | Airsep Corp. | 1996-10-25 |
| K951246 | PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONS | Protocol Systems, Inc. | 1996-02-02 |
| K894973 | RESPITRACE PLUS | Hogan & Hartson | 1989-10-30 |
| K832999 | RESPIRATION MONITOR | Litton Medical Electronics | 1984-02-13 |
| K822077 | RESPIRATION MONITOR TYPE MR-10 | New Dimensions IN Medicine, Inc. | 1982-10-06 |
| K821721 | CLINICAL DATA APNEA DETECTOR | Clinical Data, Inc. | 1982-07-13 |
| K820943 | SYSTEM I INFANT MONITORING SYS | Burr Engineering & Development Co. | 1982-05-03 |
| K810153 | VENTILATORY EFFORT MONITOR | Medicon, Inc. | 1981-02-09 |
| K802710 | INFANT APNEA MONITOR | Douglas Scientific Products | 1980-11-12 |
| K800164 | 413A NEONATAL MONITOR | Xerox Corp. | 1980-04-10 |
| K781216 | INFUSION CONTROLLER, PARENTERAL | National Patent Development Corp. | 1978-08-10 |
| K760104 | RESPIRATION MONITOR | Air-Shields, Inc. | 1976-09-21 |
| K760635 | MEDI-DYNE APNEA MONITOR | Med Dyne Inst., Inc. | 1976-09-21 |
Legacy Summary#
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FDA Review#
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