The following data is part of a premarket notification filed by King Systems Corp. with the FDA for Xenon Circuit.
| Device ID | K953513 |
| 510k Number | K953513 |
| Device Name: | XENON CIRCUIT |
| Classification | System, Rebreathing, Radionuclide |
| Applicant | KING SYSTEMS CORP. 15011 HERRIMAN BLVD. P.O. BOX 1138 Noblesville, IN 46060 |
| Contact | Michael A Leagre |
| Correspondent | Michael A Leagre KING SYSTEMS CORP. 15011 HERRIMAN BLVD. P.O. BOX 1138 Noblesville, IN 46060 |
| Product Code | IYT |
| CFR Regulation Number | 892.1390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-26 |
| Decision Date | 1995-11-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00612649169477 | K953513 | 000 |
| 00612649102832 | K953513 | 000 |
| 00612649102689 | K953513 | 000 |
| 00612649102672 | K953513 | 000 |
| 00612649102658 | K953513 | 000 |
| 00612649102641 | K953513 | 000 |
| 00612649102610 | K953513 | 000 |
| 00612649102603 | K953513 | 000 |
| 00612649102511 | K953513 | 000 |
| 00612649102504 | K953513 | 000 |
| 00612649101996 | K953513 | 000 |
| 00612649101989 | K953513 | 000 |
| 00612649165769 | K953513 | 000 |
| 00612649144078 | K953513 | 000 |
| 00612649102870 | K953513 | 000 |
| 00612649102894 | K953513 | 000 |
| 00612649103600 | K953513 | 000 |
| 00612649103556 | K953513 | 000 |
| 00612649103532 | K953513 | 000 |
| 00612649103518 | K953513 | 000 |
| 00612649103426 | K953513 | 000 |
| 00612649131207 | K953513 | 000 |
| 00612649103396 | K953513 | 000 |
| 00612649171845 | K953513 | 000 |
| 00612649103372 | K953513 | 000 |
| 00612649102931 | K953513 | 000 |
| 00612649102924 | K953513 | 000 |
| 00612649102900 | K953513 | 000 |
| 00612649101903 | K953513 | 000 |