MC Healthcare #CH31 Child's Crib
510(k) K950058
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK950058 | Date10 Feb 1995 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FMS
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5140
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
This device is a pediatric open hospital bed, specifically designed as a child's crib for use in general hospital settings. It is classified under regulation number 880.5140 and product code FMS, with a device name of Bed, Pediatric Open Hospital.
The MC Healthcare #CH31 Child's Crib received FDA 510(k) clearance K950058 on February 10, 1995, following a traditional review process. It was determined to be substantially equivalent to a predicate device and is manufactured by Janco Consulting Services in Mississauga, Ontario, Canada.
Other devices from Janco Consulting Services
Questions
AI-generated answers, 26 Sep 2026
What clinical setting is the MC Healthcare #CH31 Child's Crib intended for?
It is designed as a pediatric open hospital bed, specifically a child's crib, for use in general hospital environments. The device classification and product code (FMS) indicate it is meant for routine inpatient care of children in hospitals.
How was the MC Healthcare #CH31 Child's Crib cleared for market?
The crib received FDA 510(k) clearance (K950058) on February 10, 1995 through a traditional review process. The FDA determined it was substantially equivalent to a predicate device, which allowed it to be marketed as a Class II medical device.
Is the MC Healthcare #CH31 Child's Crib a single‑use or reusable item?
The device is a hospital bed, which by nature is a durable, reusable piece of equipment. While the FDA clearance documentation does not explicitly state reuse instructions, hospital beds are typically cleaned and maintained for repeated patient use rather than being discarded after one use.
What information is available about the manufacturer and origin of the MC Healthcare #CH31 Child's Crib?
The crib is manufactured by Janco Consulting Services, located at 6839 Montevideo Rd., Mississauga, Ontario, Canada (postal code L5N 1N7). The contact listed is Janet Shaw. This Canadian origin is reflected in the device’s registration details.
Are there any size or model variations for the MC Healthcare #CH31 Child's Crib?
The provided data identifies only one model, the #CH31 Child's Crib. No additional sizes or model variants are mentioned, so the catalogue entry refers to this single configuration as supplied by the manufacturer.