MAXO2 Cu
by Maxtec, Inc.
510(k) K063488
MAXO2 Cu is a Class II device made by Maxtec, Inc., cleared under FDA 510(k) K063488 on 22 Feb 2007, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK063488 | Date22 Feb 2007 | StatusActive |
Official records
- FDA 510(k) database K063488
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- CCL
- Device class
- Class II
- Regulation
- 21 CFR Part 868.1720
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K063488
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| MaxVenturi International DISS | R211P03-124 / International DISS | 00817770025658 | On the market | |
| MaxVenturi Muffler | R211P38-001 / Muffler | 00817770025689 | On the market | |
| MaxVenturi R211P03-019 | R211P03-019 | 00817770020981 | On the market | |
| MAXVENTURI R211P03-020 | R211P03-020 | 00817770020370 | On the market | |
| MAXVENTURI R211P03-021 | R211P03-021 | 00817770020387 | On the market | |
| MAXVENTURI R211P03-022 | R211P03-022 | 00817770020394 | On the market | |
| MAXVENTURI R211P03-023 | R211P03-023 | 00817770020400 | On the market | |
| MAXVENTURI R211P03-024 | R211P03-024 | 00817770020417 | On the market | |
| MAXVENTURI R211P03-025 | R211P03-025 | 00817770020424 | On the market | |
| MAXVENTURI R211P03-026 | R211P03-026 | 00817770020431 | On the market | |
| MAXVENTURI R211P03-027 | R211P03-027 | 00817770020448 | On the market | |
| MAXVENTURI R211P03-032 | R211P03-032 | 00817770020820 | No longer on the market | |
| MAXVENTURI R211P03-033 | R211P03-033 | 00817770020455 | On the market | |
| MAXVENTURI R211P03-034 | R211P03-034 | 00817770020462 | On the market | |
| MAXVENTURI R211P03-035 | R211P03-035 | 00817770020479 | No longer on the market | |
| MaxVenturi R211P03-036 | R211P03-036 | 00817770020912 | On the market | |
| MAXVENTURI R211P03-126 | R211P03-126 | 00817770020486 | No longer on the market | |
| MaxVenturi R211P03-127 | R211P03-127 | 00817770020882 | No longer on the market | |
| MAXVENTURI R211P24-300 | R211P24-300 | 00817770021131 | No longer on the market | |
| MAXVENTURI R211P38 | R211P38 | 00817770021148 | On the market | |
| MAXVENTURI R211P39-001 | R211P39-001 | 00817770020493 | No longer on the market | |
| MaxVenturi R211P39-002 | R211P39-002 | 00817770020899 | No longer on the market | |
| MaxVenturi R211P39-003 | R211P39-003 | 00817770020905 | No longer on the market | |
| MAXVENTURI R211P39-004 | R211P39-004 | 00817770020509 | No longer on the market | |
| Pacific Medico R211P03-018 | R211P03-018 | 00817770020875 | No longer on the market |
Similar devices
Other devices filed under FDA product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase).
- MONITOR 5590- ANALYZER 5595EC by Hudson Oxygen Therapy Sales Co.
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- Patient Monitor UX15 by Edan Instruments, Inc.
- O2-Sensor M-25T incl. Flow diverter 410220 by IT Dr. Gambert GmbH
- CERION HAND HELD OXYGEN ANALYZER by Ceramatec, Inc.
- BIO-TEK PERCENT OXYGEN MONITOR 74222 by Bio-Tek Instruments, Inc.
- Patient Monitor iM60 by Edan Instruments, Inc.
- OHMEDA 5120 OXYGEN MONITOR by Ohmeda Medical
- OPTION A02 MODEL 15202A by Hewlett-Packard Co.
- MODEL A-1 OXYGEN ANALYZER by Medical, Inc.