The following data is part of a premarket notification filed by Syncor Intl. Corp. with the FDA for Ventibox.
| Device ID | K844160 | 
| 510k Number | K844160 | 
| Device Name: | VENTIBOX | 
| Classification | Shield, Protective, Personnel | 
| Applicant | SYNCOR INTL. CORP. 12847 ARROYO ST. Sylmar, CA 91342 | 
| Contact | Eleanor V Chiu | 
| Correspondent | Eleanor V Chiu SYNCOR INTL. CORP. 12847 ARROYO ST. Sylmar, CA 91342 | 
| Product Code | KPY | 
| CFR Regulation Number | 892.6500 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1984-10-24 | 
| Decision Date | 1984-12-17 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  VENTIBOX  87010790  not registered Dead/Abandoned | JB & FT Construction Ltd. 2016-04-22 |