MC Infant Care Unie #PP30
FDA 510(k) K950059 · Janco Consulting Services
510(k) numberK950059
Submission
- Device name
- MC Infant Care Unie #PP30
- Applicant
- Janco Consulting Services
L5n 1n7, CA - Received
- January 6, 1995
- Decision date
- February 10, 1995
- 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 |
| K963210 | Vail 100 Pediatric CribFMS · Traditional | Vail Products, Inc. | 11/13/1996SE |
| 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 |
| 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 MC Infant Care Unie #PP30 cleared by the FDA?
MC Infant Care Unie #PP30 (K950059) received a 510(k) decision of Substantially Equivalent on February 10, 1995, 35 days after the submission was received.
What is the product code of K950059?
The FDA product code is FMS – Bed, Pediatric Open Hospital, a Class II (moderate risk) device regulated under 21 CFR 880.5140.