Model TI500 Isolette Infant Incubator
FDA 510(k) K941106 · Air-Shields, Inc.
510(k) numberK941106
Submission
- Device name
- Model TI500 Isolette Infant Incubator
- Applicant
- Air-Shields, Inc.
Hatboro, PA, US - Received
- March 7, 1994
- Decision date
- June 10, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FPL – Incubator, Neonatal Transport
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5410
- Specialty
- General Hospital
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|---|---|---|---|
| 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 |
|---|---|---|
| K974248 | Watchchild Obsterical Patient Data Management SystemHGM · Traditional | 10/07/1998SE |
| K972309 | JM-102 Jaundice MeterMQM · Traditional | 09/22/1998SE |
| K971256 | Duo-Lite Phototherapy SystemLBI · Traditional | 09/24/1997SE |
| K960980 | Isolette Infant IncubatorFMZ · Traditional | 07/30/1996SE |
| K924709 | Satcare Oxygen Controller/Monitor W/ Pulse OximeteKLK · Traditional | 01/17/1996SE |
| K940951 | RW Resucitaire Infant Radiant WarmerFMT · Traditional | 05/03/1995SE |
| K940975 | C450/C400 Infant IncubatorsFMZ · Traditional | 06/23/1994SE |
| K924170 | Isolette Incubator Humidity MeterFMZ · Traditional | 02/05/1993SE |
| K922150 | Examination LampKZF · Traditional | 07/21/1992SE |
| K914864 | Models C500/C550 Isolete(R) Infant IncubatorFMZ · Traditional | 03/13/1992SE |
Questions and answers
When was Model TI500 Isolette Infant Incubator cleared by the FDA?
Model TI500 Isolette Infant Incubator (K941106) received a 510(k) decision of Substantially Equivalent on June 10, 1994, 95 days after the submission was received.
What is the product code of K941106?
The FDA product code is FPL – Incubator, Neonatal Transport, a Class II (moderate risk) device regulated under 21 CFR 880.5410.