Babytherm 8000 WB
FDA 510(k) K945467 · Drager, Inc.
510(k) numberK945467
Submission
- Device name
- Babytherm 8000 WB
- Applicant
- Drager, Inc.
Chantilly, VA, US - Received
- November 7, 1994
- Decision date
- April 28, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- ILO – Pack, Hot Or Cold, Water Circulating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5720
- Specialty
- Physical Medicine
Other 510(k)s with product code ILO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K213097 | Armory MotionILO · Traditional | Pain Management Technologies, Inc. | 06/10/2022SE |
| K083008 | CoolskinILO · Abbreviated | Elbio Co., Ltd. | 06/10/2009SE |
| K073675 | T-Pump Localized Temperature Therapy PumpILO · Traditional | Gaymar Industries, Inc. | 05/08/2008SE |
| K072152 | Juniper CLN1 Dermal Cooling DeviceILO · Traditional | Juniper Medical, Inc. | 09/07/2007SE |
| K070402 | Modification to Polar Care 500ILO · Special | Breg, Inc. | 03/29/2007SE |
| K040317 | Ivc SystemILO · Traditional | Mark H. Friedman | 05/07/2004SE |
| K973023 | Incare Hot/Ice System Foot/Ankle BlanketILO · Traditional | Hollister, Inc. | 11/03/1997SE |
| K970197 | HTP-1500 Localized Heat Therapy PumpILO · Traditional | Adroit Medical Systems, Inc. | 09/10/1997SE |
| K964799 | Artrotherm Cryotherapy and ThernotherapyILO · Traditional | Ormed GmbH | 08/29/1997SE |
| K964354 | Artocool-S Water Circulating Cold PackILO · Traditional | Ormed GmbH | 08/29/1997SE |
More from Ormed GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K992608 | Atc Option for Evita 2 Dura and Evita 4CBK · Special | 08/24/1999SE |
| K984577 | Drager Oxylog 2000CBK · Special | 01/22/1999SE |
| K983219 | Neoflow Option Model Numbers 8413563, 8411900CBK · Traditional | 12/07/1998SE |
| K982789 | Medical Air Compressor, Model # 8413419BTI · Traditional | 10/29/1998SE |
| K980642 | Evita 4 (8411900)CBK · Traditional | 09/04/1998SE |
| K974176 | Babylog 8000 PlusCBK · Traditional | 06/17/1998SE |
| K971198 | Babytherm 8004 Babytherm 8010FMT · Traditional | 10/03/1997SE |
| K970165 | Evita 2 DuraCBK · Traditional | 08/26/1997ST |
| K954204 | Drager Incubator 8000 IcFMZ · Traditional | 04/25/1997SE |
| K961687 | Evita 4CBK · Traditional | 12/13/1996ST |
Questions and answers
When was Babytherm 8000 WB cleared by the FDA?
Babytherm 8000 WB (K945467) received a 510(k) decision of Substantially Equivalent on April 28, 1995, 172 days after the submission was received.
What is the product code of K945467?
The FDA product code is ILO – Pack, Hot Or Cold, Water Circulating, a Class II (moderate risk) device regulated under 21 CFR 890.5720.