Sensori-Motor Rating Scale
FDA 510(k) K946114 · Cmed
510(k) numberK946114
Submission
- Device name
- Sensori-Motor Rating Scale
- Applicant
- Cmed
Irvine, CA, US - Received
- December 15, 1994
- Decision date
- April 28, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code IXY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K953402 | Universix 190IXY · Traditional | Philips Medical Systems (Cleveland), Inc. | 08/11/1995SE |
| K953336 | VRS 3 Wall StandIXY · Traditional | Philips Medical Systems (Cleveland), Inc. | 08/11/1995SE |
| K946260 | NTBS-1417, 1436, TBS-1417IXY · Traditional | Scott Imaging Intl., Inc. | 03/31/1995SE |
| K930249 | Bc/Wt/PfIXY · Traditional | Tingle X-Ray Products, Inc. | 04/27/1993SE |
| K930230 | Radiographic Wall-Mounted Cassette HolderIXY · Traditional | American Medical Sales, Inc. | 04/27/1993SE |
| K925934 | Wall Bucky Holders Lt. & Rt. Hand, & Center MountIXY · Traditional | Continental X-Ray Corp. | 03/04/1993SE |
| K924445 | BA-4 Wall Bucky and BA-42 Tilting Wall BuckyIXY · Traditional | Control-X, Inc. | 02/19/1993SE |
| K922443 | Vert-X Universal Vertical Bucky StandIXY · Traditional | Afp Imaging Corp. | 10/26/1992SE |
| K915667 | Model H170 Pediatric Chest X-Ray UnitIXY · Traditional | H.L. Lyons Co. | 01/31/1992SE |
| K895034 | Buckys Models YMB-15A, YMB-15B and YMB-15CIXY · Traditional | Yamato Medical Corp. | 11/15/1989SE |
More from Yamato Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K981157 | Stable FlowFPA · Traditional | 06/16/1998SE |
Questions and answers
When was Sensori-Motor Rating Scale cleared by the FDA?
Sensori-Motor Rating Scale (K946114) received a 510(k) decision of Substantially Equivalent on April 28, 1995, 134 days after the submission was received.
What is the product code of K946114?
The FDA product code is IXY – Holder, Radiographic Cassette, Wall-Mounted, a Class I (low risk) device regulated under 21 CFR 892.1880.