FPL — Incubator, Neonatal Transport Class II
FDA Device Classification
Classification Details
- Product Code
- FPL
- Device Class
- Class II
- Regulation Number
- 880.5410
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K220742 | international biomedical | NxtGen Infant Transport Incubator | July 15, 2022 |
| K161918 | advanced imaging research dba sree medical systems | SREE MRI Transport Incubator | March 3, 2017 |
| K141565 | draeger medical systems | GLOBE-TROTTER GT5400 | September 10, 2014 |
| K123937 | atom medical corporation | ATOM TRANSCAPSULE V-707 | May 23, 2013 |
| K103525 | international biomedical | A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NE | May 11, 2011 |
| K103523 | international biomedical | 185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NE | May 11, 2011 |
| K103527 | international biomedical | AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WIT | April 15, 2011 |
| K103524 | international biomedical | VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WIT | April 15, 2011 |
| K081399 | international biomedical | AVIATOR TRANSPORT INCUBATOR | June 6, 2008 |
| K061071 | atom medical | V-808 ATOM TRANSCAPSULE | August 29, 2006 |
| K062052 | lmt lammers medical technology | LMT NOMAG IC 3.0 | July 31, 2006 |
| K033565 | lmt lammers medical technology | LMT NOMAG IC 1,5 | November 21, 2003 |
| K031096 | international biomedics | MODIFICATION TO TRANSPORT INCUBATOR 185 | June 24, 2003 |
| K022876 | international biomedical | MODIFICATION TO INFANT LIFE SUPPORT MODULE-20 | September 11, 2002 |
| K001019 | hill-rom air-shields | TI500 GLOBE-TROTTER TRANSPORT SYSTEM | April 27, 2000 |
| K941106 | air-shields | MODEL TI500 ISOLETTE INFANT INCUBATOR | June 10, 1994 |
| K932417 | ferno-washington | FERNO WASHINGTON INCUBATOR TRANSPORTER, MOD. 35-IT | September 9, 1993 |
| K931346 | ferno | FERNO-WASHINGTON INCUBATOR TRANSPORTER,# 29-IT | August 25, 1993 |
| K893624 | preemicare | PREEMICARE MODEL 2500 TRANSPORT WARMER | September 27, 1989 |
| K854065 | intl. biomedics | INFANT LIFE SUPPORT MODULE-20 | January 16, 1986 |