The following data is part of a premarket notification filed by Atomic Products Corp. with the FDA for Venti-scan Ii.
| Device ID | K871868 |
| 510k Number | K871868 |
| Device Name: | VENTI-SCAN II |
| Classification | System, Rebreathing, Radionuclide |
| Applicant | ATOMIC PRODUCTS CORP. P.O. DRAWER R Shirley, NY 11967 |
| Contact | James Reiss |
| Correspondent | James Reiss ATOMIC PRODUCTS CORP. P.O. DRAWER R Shirley, NY 11967 |
| Product Code | IYT |
| CFR Regulation Number | 892.1390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-13 |
| Decision Date | 1988-04-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00718175001929 | K871868 | 000 |
| 00718175001912 | K871868 | 000 |
| 30718175005157 | K871868 | 000 |
| 00718175087626 | K871868 | 000 |
| 00879942070170 | K871868 | 000 |
| 00879942070163 | K871868 | 000 |
| 00879942070156 | K871868 | 000 |
| 00879942070149 | K871868 | 000 |