The following data is part of a premarket notification filed by Vital Science Corp. with the FDA for Quantascope.
| Device ID | K870442 |
| 510k Number | K870442 |
| Device Name: | QUANTASCOPE |
| Classification | Ballistocardiograph |
| Applicant | VITAL SCIENCE CORP. BOETTCHER BLDG. SUITE 625 8400 EAST PRENTICE AVENUE Englewood, CO 80111 |
| Contact | Donald J Zahorik |
| Correspondent | Donald J Zahorik VITAL SCIENCE CORP. BOETTCHER BLDG. SUITE 625 8400 EAST PRENTICE AVENUE Englewood, CO 80111 |
| Product Code | DXR |
| CFR Regulation Number | 870.2320 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-03 |
| Decision Date | 1987-08-11 |