The following data is part of a premarket notification filed by Maxtec, Inc. with the FDA for Maxo2 Cu.
| Device ID | K063488 |
| 510k Number | K063488 |
| Device Name: | MAXO2 CU |
| Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
| Applicant | MAXTEC, INC. 3460 POINTE CREEK CT. # 102 Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden MAXTEC, INC. 3460 POINTE CREEK CT. # 102 Bonita Springs, FL 34134 |
| Product Code | CCL |
| CFR Regulation Number | 868.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-17 |
| Decision Date | 2007-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817770021148 | K063488 | 000 |
| 00817770020455 | K063488 | 000 |
| 00817770020448 | K063488 | 000 |
| 00817770020431 | K063488 | 000 |
| 00817770020424 | K063488 | 000 |
| 00817770020417 | K063488 | 000 |
| 00817770020400 | K063488 | 000 |
| 00817770020394 | K063488 | 000 |
| 00817770020387 | K063488 | 000 |
| 00817770020370 | K063488 | 000 |
| 00817770025689 | K063488 | 000 |
| 00817770020462 | K063488 | 000 |
| 00817770020479 | K063488 | 000 |
| 00817770020486 | K063488 | 000 |
| 00817770021131 | K063488 | 000 |
| 00817770020981 | K063488 | 000 |
| 00853061006296 | K063488 | 000 |
| 00817770020905 | K063488 | 000 |
| 00817770020899 | K063488 | 000 |
| 00817770020882 | K063488 | 000 |
| 00817770020875 | K063488 | 000 |
| 00817770020820 | K063488 | 000 |
| 00817770020509 | K063488 | 000 |
| 00817770020493 | K063488 | 000 |
| 00817770025658 | K063488 | 000 |