Panels › General Hospital › Product code FPL · Class 2
Incubator, Neonatal Transport
Regulation 880.5410
0510(k)s in 12 months (25 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in FPL
| Company | 510(k)s | Recalls |
|---|---|---|
| International Biomedical | 7 | 0 |
| Atom Medical Corporation | 2 | 0 |
| Draeger Medical Systems, Inc. | 1 | 1 |
| Lmt Lammers Medical Technology GmbH | 2 | 0 |
| Advanced Imaging Research Dba Sree Medical Systems | 1 | 0 |
| Air-Shields, Inc. | 1 | 0 |
| Airborne Life Support Systems, Inc. | 1 | 0 |
| Cavitron Corp. | 1 | 0 |
| Ferno | 1 | 0 |
| Ferno-Washington, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 15, 2022 | K220742 | NxtGen Infant Transport Incubator International Biomedical | FPL |
| Mar 3, 2017 | K161918 | SREE MRI Transport Incubator Advanced Imaging Research Dba Sree Medical Systems | FPL |
| Sep 10, 2014 | K141565 | GLOBE-TROTTER GT5400 Draeger Medical Systems, Inc. | FPL |
| May 23, 2013 | K123937 | ATOM TRANSCAPSULE V-707 Atom Medical Corporation | FPL |
| May 11, 2011 | K103525 | A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX International Biomedical, Ltd. | FPL |
| May 11, 2011 | K103523 | 185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX International Biomedical, Ltd. | FPL |
| Apr 15, 2011 | K103527 | AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX International Biomedical, Ltd. | FPL |
| Apr 15, 2011 | K103524 | VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX International Biomedical, Ltd. | FPL |
| Jun 6, 2008 | K081399 | AVIATOR TRANSPORT INCUBATOR International Biomedical, Ltd. | FPL |
| Aug 29, 2006 | K061071 | V-808 ATOM TRANSCAPSULE Atom Medical, Inc. | FPL |
| Jul 31, 2006 | K062052 | LMT NOMAG IC 3.0 Lmt Lammers Medical Technology GmbH, DE | FPL |
| Nov 21, 2003 | K033565 | LMT NOMAG IC 1,5 Lmt Lammers Medical Technology GmbH, DE | FPL |
| Jun 24, 2003 | K031096 | MODIFICATION TO TRANSPORT INCUBATOR 185 International Biomedics, Inc. | FPL |
| Sep 11, 2002 | K022876 | MODIFICATION TO INFANT LIFE SUPPORT MODULE-20 International Biomedical, Inc. | FPL |
| Apr 27, 2000 | K001019 | TI500 GLOBE-TROTTER TRANSPORT SYSTEM Hill-Rom Air-Shields | FPL |
| Jun 10, 1994 | K941106 | MODEL TI500 ISOLETTE INFANT INCUBATOR Air-Shields, Inc. | FPL |
| Sep 9, 1993 | K932417 | FERNO WASHINGTON INCUBATOR TRANSPORTER, MOD. 35-IT Ferno-Washington, Inc. | FPL |
| Aug 25, 1993 | K931346 | FERNO-WASHINGTON INCUBATOR TRANSPORTER,# 29-IT Ferno | FPL |
| Sep 27, 1989 | K893624 | PREEMICARE MODEL 2500 TRANSPORT WARMER Preemicare Corp. | FPL |
| Jan 16, 1986 | K854065 | INFANT LIFE SUPPORT MODULE-20 Intl. Biomedics, Inc. | FPL |
| May 23, 1985 | K850496 | TRANSPORT INCUBATOR 185 Airborne Life Support Systems, Inc. | FPL |
| May 9, 1983 | K831028 | TI-1000 TRANSPORT INCUBATOR Narco Scientific | FPL |
| May 29, 1979 | K790689 | REVISED BATTERY CHARGER Vickers America Medical Corp. | FPL |
| Apr 24, 1979 | K790551 | TRANSPORT INCUBATOR Narco Air-Shields | FPL |
| Jul 27, 1978 | K780964 | TRANSPORT INCUBATOR Cavitron Corp. | FPL |
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