FPL — Incubator, Neonatal Transport Class II
FDA product code FPL covers "Incubator, Neonatal Transport", a Class II medical device regulated under 21 CFR 880.5410. 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
- 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 |
| K103523 | international biomedical | 185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NE | May 11, 2011 |
| K103525 | international biomedical | A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NE | May 11, 2011 |
| K103524 | international biomedical | VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WIT | April 15, 2011 |
| K103527 | international biomedical | AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR 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 |