The following data is part of a premarket notification filed by Devmed Corp. with the FDA for Devmed Stepping And Stabilizing System.
| Device ID | K972152 |
| 510k Number | K972152 |
| Device Name: | DEVMED STEPPING AND STABILIZING SYSTEM |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | DEVMED CORP. 2655 NORTH OCEAN DR. Singer Island, FL 33404 |
| Contact | Greg Wiita |
| Correspondent | Greg Wiita DEVMED CORP. 2655 NORTH OCEAN DR. Singer Island, FL 33404 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-09 |
| Decision Date | 1997-08-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00801741079207 | K972152 | 000 |
| 00801741078910 | K972152 | 000 |
| 00801741078927 | K972152 | 000 |
| 00801741078934 | K972152 | 000 |
| 00801741078941 | K972152 | 000 |
| 00801741078958 | K972152 | 000 |
| 00801741078965 | K972152 | 000 |
| 00801741078972 | K972152 | 000 |
| 00801741078989 | K972152 | 000 |
| 00801741079016 | K972152 | 000 |
| 00801741079023 | K972152 | 000 |
| 00801741079030 | K972152 | 000 |
| 00801741079078 | K972152 | 000 |
| 00801741079085 | K972152 | 000 |
| 00801741079153 | K972152 | 000 |
| 00801741079160 | K972152 | 000 |
| 00801741079184 | K972152 | 000 |
| 00801741079191 | K972152 | 000 |
| 00801741078873 | K972152 | 000 |