Warm Weigh Models I-20/W-30 Infant Scale
FDA 510(k) K872742 · Air-Shields, Inc.
510(k) numberK872742
Submission
- Device name
- Warm Weigh Models I-20/W-30 Infant Scale
- Applicant
- Air-Shields, Inc.
Hatboro, PA, US - Received
- July 10, 1987
- Decision date
- October 20, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| 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 |
| 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 |
Questions and answers
When was Warm Weigh Models I-20/W-30 Infant Scale cleared by the FDA?
Warm Weigh Models I-20/W-30 Infant Scale (K872742) received a 510(k) decision of Substantially Equivalent on October 20, 1987, 102 days after the submission was received.
What is the product code of K872742?
The FDA product code is FMT – Warmer, Infant Radiant, a Class II (moderate risk) device regulated under 21 CFR 880.5130.