KMI — Monitor, Bed Patient Class I
FDA product code KMI covers "Monitor, Bed Patient", a Class I medical device regulated under 21 CFR 880.2400. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KMI
- Device Class
- Class I
- Regulation Number
- 880.2400
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K141877 | leaf healthcare | LEAF PATIENT MONITORING SYSTEM | November 10, 2014 |
| K131585 | intel-ge care innovations | INTEL-GE CARE INNOVATIONS QUIETCARE | October 8, 2013 |
| K130752 | centauri medical | DYNASENSE SYSTEM | August 15, 2013 |
| K101109 | wireless medcare | VIVATRAK | July 15, 2010 |
| K090138 | aframe digital | MOBILECARE MONITOR, MODEL 2100 | April 24, 2009 |
| K942770 | ultimate development | ULTIMAT-SENSOR FOR BED OCCUPANCY MONITOR | December 23, 1994 |
| K943481 | micro-tech medical | INFORMER PLUS | November 2, 1994 |
| K933552 | hill engineering | PM-PAGER | September 22, 1994 |
| K934344 | medway | HOME AMB-ALERT | April 29, 1994 |
| K940405 | berchtold holding | TELETOM | April 14, 1994 |
| K924433 | senior technologies | SENIOR TECH TABS 88 TRANS RA1/WRA1/R1 ANN TYPE CR1 | June 24, 1993 |
| K925529 | care electronics | WANDER CARE | June 16, 1993 |
| K920206 | j. t. posey | POSEY SITTER | May 14, 1992 |
| K914859 | bartronix | BARTRONIX IN-BED ACTIVITY MONITOR | April 13, 1992 |
| K911079 | medway | AMB-ALERT | September 13, 1991 |
| K905586 | tactilitics | RSVP RF-2000 | April 1, 1991 |
| K905421 | alertcare | EXIT ALARM | February 12, 1991 |
| K901969 | alertronics | ALERT BED ALARM SYSTEM | September 12, 1990 |
| K901330 | monitor | THE MONITOR ELECTRONIC BED ALARM SYSTEM | August 30, 1990 |
| K883390 | datatek | PMD SYSTEM-20 | October 25, 1988 |