RW Resucitaire Infant Radiant Warmer
FDA 510(k) K940951 · Air-Shields, Inc.
510(k) numberK940951
Submission
- Device name
- RW Resucitaire Infant Radiant Warmer
- Applicant
- Air-Shields, Inc.
Hatboro, PA, US - Received
- March 2, 1994
- Decision date
- May 3, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FMT – Warmer, Infant Radiant
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5130
- Specialty
- General Hospital
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| K940975 | C450/C400 Infant IncubatorsFMZ · Traditional | 06/23/1994SE |
| K941106 | Model TI500 Isolette Infant IncubatorFPL · Traditional | 06/10/1994SE |
| 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 RW Resucitaire Infant Radiant Warmer cleared by the FDA?
RW Resucitaire Infant Radiant Warmer (K940951) received a 510(k) decision of Substantially Equivalent on May 3, 1995, 427 days after the submission was received.
What is the product code of K940951?
The FDA product code is FMT – Warmer, Infant Radiant, a Class II (moderate risk) device regulated under 21 CFR 880.5130.