MONITORING KIT AMK-1
FDA 510(k) clearance K830778 · decided 1983-10-14
Clearance details
- K-number
- K830778
- Device name
- MONITORING KIT AMK-1
- Applicant
- Alternative Design Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-03-11
- Decision date
- 1983-10-14
- Days to decision
- 217 days
- Clearance type
- Traditional
- Product code
- FLS
- Device class
- 2
- Regulation number
- 868.2377
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Alternative Design Systems
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SMARTMONITOR 2, MODEL 4000 (K011597) | Respironics Georgia, Inc. | 2002-01-11 |
| HANNAH WIRELESS VITAL SIGNS MONITOR (K991087) | Ilife Systems, Inc. | 2000-01-12 |
| REMBRANDT SYSTEM (K962865) | Airsep Corp. | 1996-10-25 |
| PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONS (K951246) | Protocol Systems, Inc. | 1996-02-02 |
| RESPITRACE PLUS (K894973) | Hogan & Hartson | 1989-10-30 |
| RESPIRATION MONITOR (K832999) | Litton Medical Electronics | 1984-02-13 |
| RESPIRATION MONITOR TYPE MR-10 (K822077) | New Dimensions IN Medicine, Inc. | 1982-10-06 |
| CLINICAL DATA APNEA DETECTOR (K821721) | Clinical Data, Inc. | 1982-07-13 |
| SYSTEM I INFANT MONITORING SYS (K820943) | Burr Engineering & Development Co. | 1982-05-03 |
| VENTILATORY EFFORT MONITOR (K810153) | Medicon, Inc. | 1981-02-09 |
| INFANT APNEA MONITOR (K802710) | Douglas Scientific Products | 1980-11-12 |
| 413A NEONATAL MONITOR (K800164) | Xerox Corp. | 1980-04-10 |
Recalls involving this device
No recalls on record reference this clearance.