Vail 100 Pediatric Crib
FDA 510(k) K963210 · Vail Products, Inc.
510(k) numberK963210
Submission
- Device name
- Vail 100 Pediatric Crib
- Applicant
- Vail Products, Inc.
Toledo, OH, US - Received
- August 16, 1996
- Decision date
- November 13, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FMS – Bed, Pediatric Open Hospital
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5140
- Specialty
- General Hospital
Other 510(k)s with product code FMS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K970334 | Nature's CradleFMS · Traditional | Infant Advantage, Inc. | 04/25/1997SE |
| K960747 | Nature's Cradle Model C1500FMS · Traditional | Infant Advantage, Inc. | 05/22/1996SE |
| K960012 | Stryker Adel BassinetFMS · Traditional | Stryker Corp. | 03/25/1996SE |
| K951024 | Nature's CradleFMS · Traditional | Infant Advantage, Inc. | 06/05/1995SE |
| K950059 | MC Infant Care Unie #PP30FMS · Traditional | Janco Consulting Services | 02/10/1995SE |
| K950058 | MC Healthcare #CH31 Child's CribFMS · Traditional | Janco Consulting Services | 02/10/1995SE |
| K950051 | Brewer Company Teddy Crib Model 71900-A, B, 71910-A, BFMS · Traditional | The Brewer Co. | 02/10/1995SE |
| K925530 | Instrument WarmerFMS · Traditional | Superior Healthcare Group, Inc. | 06/18/1993SE |
| K925949 | Pedicragt BassinetFMS · Traditional | Pedicraft, Inc. | 04/20/1993SE |
| K925817 | Head & Foot End Drop Pedi-CribFMS · Traditional | Pedicraft, Inc. | 04/20/1993SE |
More from Pedicraft, Inc.
Questions and answers
When was Vail 100 Pediatric Crib cleared by the FDA?
Vail 100 Pediatric Crib (K963210) received a 510(k) decision of Substantially Equivalent on November 13, 1996, 89 days after the submission was received.
What is the product code of K963210?
The FDA product code is FMS – Bed, Pediatric Open Hospital, a Class II (moderate risk) device regulated under 21 CFR 880.5140.