510(k) K103525
- Device
- A750I TRANSPORT INCUBATOR WITH MASIMO PLUSEOX, A750I TRANSPORT INCUBATOR WITH NELLOR PULSEOX
- Applicant
- INTERNATIONAL BIOMEDICAL, LTD.
- 510(k) number
- K103525
- Product code
- FPL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-05-11
- Date received
- 2010-12-01
- Regulation
- 880.5410
- Classification name
- Incubator, Neonatal Transport
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- AMY PIEPER
- Address
- 8508 Cross Park Dr. Austin TX US 78754 78754
FDA Registration Numbers#
- 3009514037
- 3005934741
- 2510954
- 1054713
- 8021995
- 3012348048
- 3006891627
- 1625392
- 3005652389
- 1066270
Source Documents#
Other 510(k) Records For Product Code FPL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K220742 | NxtGen Infant Transport Incubator | International Biomedical | 2022-07-15 |
| K161918 | SREE MRI Transport Incubator | Advanced Imaging Research Dba Sree Medical Systems | 2017-03-03 |
| K141565 | GLOBE-TROTTER GT5400 | Draeger Medical Systems, Inc. | 2014-09-10 |
| K123937 | ATOM TRANSCAPSULE V-707 | Atom Medical Corporation | 2013-05-23 |
| K103523 | 185A+ TRANSPORT INCUBATOR WITH MASIMO PULSEOX, 185A+ TRANSPORT INCUBATOR WITH NELLCOR PULSEOX | International Biomedical, Ltd. | 2011-05-11 |
| K103524 | VOYAGER TRANSPORT INCUBATOR WITH MASIMO PULSEOX, VOYAGER TRANSPORT INCUBATOR WITH NELLCOR PULSEOX | International Biomedical, Ltd. | 2011-04-15 |
| K103527 | AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX | International Biomedical, Ltd. | 2011-04-15 |
| K081399 | AVIATOR TRANSPORT INCUBATOR | International Biomedical, Ltd. | 2008-06-06 |
| K061071 | V-808 ATOM TRANSCAPSULE | Atom Medical, Inc. | 2006-08-29 |
| K062052 | LMT NOMAG IC 3.0 | Lmt Lammers Medical Technology GmbH | 2006-07-31 |
| K033565 | LMT NOMAG IC 1,5 | Lmt Lammers Medical Technology GmbH | 2003-11-21 |
| K031096 | MODIFICATION TO TRANSPORT INCUBATOR 185 | International Biomedics, Inc. | 2003-06-24 |
| K022876 | MODIFICATION TO INFANT LIFE SUPPORT MODULE-20 | International Biomedical, Inc. | 2002-09-11 |
| K001019 | TI500 GLOBE-TROTTER TRANSPORT SYSTEM | Hill-Rom Air-Shields | 2000-04-27 |
| K941106 | MODEL TI500 ISOLETTE INFANT INCUBATOR | Air-Shields, Inc. | 1994-06-10 |
Legacy Summary#
summary
FDA Review#
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