REMBRANDT SYSTEM
FDA 510(k) clearance K962865 · decided 1996-10-25
Clearance details
- K-number
- K962865
- Device name
- REMBRANDT SYSTEM
- Applicant
- Airsep Corp.
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Date received
- 1996-07-23
- Decision date
- 1996-10-25
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- FLS
- Device class
- 2
- Regulation number
- 868.2377
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Buffalo, NY, US
- Third-party review
- No
- Expedited review
- No
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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 |
| 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 |
| MONITORING KIT AMK-1 (K830778) | Alternative Design Systems, Inc. | 1983-10-14 |
| 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.