Preemicare Model 2500 Transport Warmer
FDA 510(k) K893624 · Preemicare Corp.
510(k) numberK893624
Submission
- Device name
- Preemicare Model 2500 Transport Warmer
- Applicant
- Preemicare Corp.
Houston, TX, US - Received
- May 11, 1989
- Decision date
- September 27, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FPL – Incubator, Neonatal Transport
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5410
- Specialty
- General Hospital
Other 510(k)s with product code FPL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220742 | NxtGen Infant Transport IncubatorFPL · Traditional | International Biomedical | 07/15/2022SE |
| K161918 | SREE MRI Transport IncubatorFPL · Traditional | Advanced Imaging Research Dba Sree Medical Systems | 03/03/2017SE |
| K141565 | Globe-Trotter GT5400FPL · Traditional | Draeger Medical Systems, Inc. | 09/10/2014SE |
| K123937 | Atom Transcapsule V-707FPL · Traditional | Atom Medical Corporation | 05/23/2013SE |
| K103525 | A750I Transport Incubator with Masimo Pluseox, A750I Transport Incubator with Nellor…FPL · Special | International Biomedical, Ltd. | 05/11/2011SE |
| K103523 | 185A+ Transport Incubator with Masimo Pulseox, 185A+ Transport Incubator with Nellcor…FPL · Special | International Biomedical, Ltd. | 05/11/2011SE |
| K103527 | Aviator Transport Incubator with Masimo Pulseox, Aviator Transport Incubator with…FPL · Special | International Biomedical, Ltd. | 04/15/2011SE |
| K103524 | Voyager Transport Incubator with Masimo Pulseox, Voyager Transport Incubator with…FPL · Special | International Biomedical, Ltd. | 04/15/2011SE |
| K081399 | Aviator Transport IncubatorFPL · Special | International Biomedical, Ltd. | 06/06/2008SE |
| K061071 | V-808 Atom TranscapsuleFPL · Traditional | Atom Medical, Inc. | 08/29/2006SE |
More from Atom Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K911450 | Infant VentilatorCBK · Traditional | 06/18/1991SE |
| K896375 | Preemicare Nebutech Nebulizer SystemCAF · Traditional | 10/29/1990SE |
| K900735 | Model 130 Automatic Height Adjust (Aha) IncubatorFMZ · Traditional | 05/02/1990SE |
| K893622 | Preemicare Model 200-II Infant Transport Ventil.CBK · Traditional | 01/03/1990SE |
| K891674 | Neonatal Environmental Monitor, Model 275CCL · Traditional | 08/31/1989SE |
| K885350 | Preemicare Series 2000 Infant WarmerFMT · Traditional | 08/07/1989SE |
| K884133 | Preemicare Series 4000 Phototherapy LampLBI · Traditional | 03/08/1989SE |
| K881476 | Preemicare Model D1-X1, Series 3000FMZ · Traditional | 12/08/1988SE |
Questions and answers
When was Preemicare Model 2500 Transport Warmer cleared by the FDA?
Preemicare Model 2500 Transport Warmer (K893624) received a 510(k) decision of Substantially Equivalent on September 27, 1989, 139 days after the submission was received.
What is the product code of K893624?
The FDA product code is FPL – Incubator, Neonatal Transport, a Class II (moderate risk) device regulated under 21 CFR 880.5410.