The following data is part of a premarket notification filed by Medical Positioning, Inc. with the FDA for Mortara Stress Echo Bed.
| Device ID | K082967 |
| 510k Number | K082967 |
| Device Name: | MORTARA STRESS ECHO BED |
| Classification | Electrocardiograph |
| Applicant | MEDICAL POSITIONING, INC. 21521 HUMMINGBIRD STREET Trabuco Canyon, CA 92679 |
| Contact | Carol White |
| Correspondent | Carol White MEDICAL POSITIONING, INC. 21521 HUMMINGBIRD STREET Trabuco Canyon, CA 92679 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-06 |
| Decision Date | 2009-03-26 |
| Summary: | summary |