Ferno-Washington Incubator Transporter,# 29-IT
FDA 510(k) K931346 · Ferno
510(k) numberK931346
Submission
- Device name
- Ferno-Washington Incubator Transporter,# 29-IT
- Applicant
- Ferno
Wilmington, OH, US - Received
- March 17, 1993
- Decision date
- August 25, 1993
- 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
Other 510(k)s with product code FPL
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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 |
|---|---|---|
| K932260 | Ferno-Washington Ambulance Cot, 93ES Squad-MateFPO · Traditional | 09/09/1993SE |
| K924669 | Ferno-Washington Basket Stretcher, Model 71-WFPP · Traditional | 04/29/1993SE |
| K924023 | Ferno Ille Inferno Moist Heat Therapy Ut, 916/917IRQ · Traditional | 04/14/1993SE |
| K914125 | Ferno Ille Hi-Lo Jr. Mobile Whirlpool, Model 403ILJ · Traditional | 10/25/1991SE |
Questions and answers
When was Ferno-Washington Incubator Transporter,# 29-IT cleared by the FDA?
Ferno-Washington Incubator Transporter,# 29-IT (K931346) received a 510(k) decision of Substantially Equivalent on August 25, 1993, 161 days after the submission was received.
What is the product code of K931346?
The FDA product code is FPL – Incubator, Neonatal Transport, a Class II (moderate risk) device regulated under 21 CFR 880.5410.