Contor Table Surface
FDA 510(k) K973705 · Hill-Rom, Inc.
510(k) numberK973705
Submission
- Device name
- Contor Table Surface
- Applicant
- Hill-Rom, Inc.
Charleston, SC, US - Received
- September 29, 1997
- Decision date
- August 7, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DWJ – System, Thermal Regulating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5900
- Specialty
- Cardiovascular
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K143414 | Hill-Rom Wireless Connectivity ModuleIOQ · Traditional | 03/10/2015SE |
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| K112502 | Procedural Strecher with Intellidrive P8000INK · Traditional | 09/19/2011SE |
| K013709 | Hill-Rom Primaview Monitor SystemFET · Traditional | 11/16/2001SE |
| K981081 | BrightstarFSY · Traditional | 04/29/1998SE |
| K972111 | Rumors Dynamic Air Therapy UnitIKZ · Traditional | 02/02/1998SE |
| K971366 | IncuwarmerFMT · Traditional | 01/05/1998SE |
Questions and answers
When was Contor Table Surface cleared by the FDA?
Contor Table Surface (K973705) received a 510(k) decision of Substantially Equivalent on August 7, 1998, 312 days after the submission was received.
What is the product code of K973705?
The FDA product code is DWJ – System, Thermal Regulating, a Class II (moderate risk) device regulated under 21 CFR 870.5900.