The following data is part of a premarket notification filed by Medtec, Inc. D/b/a Civco Medical Solutions with the FDA for Body Pro-lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-respiratory Belt, Rail Clamp For Respiratory Belt, Pressure Gauge Replacement.
| Device ID | K153026 |
| 510k Number | K153026 |
| Device Name: | Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp For Respiratory Belt, Pressure Gauge Replacement |
| Classification | Accelerator, Linear, Medical |
| Applicant | MEDTEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS 1401 8TH STREET SE Orange City, IA 51041 |
| Contact | Amanda Stahle |
| Correspondent | Amanda Stahle MEDTEC, INC. D/B/A CIVCO MEDICAL SOLUTIONS 1401 8TH STREET SE Orange City, IA 51041 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-16 |
| Decision Date | 2016-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841439110447 | K153026 | 000 |
| 00841439110355 | K153026 | 000 |
| 00841439107263 | K153026 | 000 |
| 00841439102282 | K153026 | 000 |
| 00841439113561 | K153026 | 000 |
| 00841439110454 | K153026 | 000 |
| 00841439113554 | K153026 | 000 |