The following data is part of a premarket notification filed by Alliance Tech Medical, Inc. with the FDA for All Flow Pulmonary Function Filter.
| Device ID | K043148 |
| 510k Number | K043148 |
| Device Name: | ALL FLOW PULMONARY FUNCTION FILTER |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | ALLIANCE TECH MEDICAL, INC. 611 SOUTH SCHOOLHOUSE CREEK RD Grants Pass, OR 97526 |
| Contact | Keith Lowrey |
| Correspondent | Keith Lowrey ALLIANCE TECH MEDICAL, INC. 611 SOUTH SCHOOLHOUSE CREEK RD Grants Pass, OR 97526 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-15 |
| Decision Date | 2004-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00384620000054 | K043148 | 000 |
| 00384620000016 | K043148 | 000 |
| 00384620000023 | K043148 | 000 |
| 00384620000030 | K043148 | 000 |
| 00384620000047 | K043148 | 000 |
| 00384620000061 | K043148 | 000 |
| 00384620000078 | K043148 | 000 |
| 00384620000085 | K043148 | 000 |
| 00384620000092 | K043148 | 000 |
| 00384620000108 | K043148 | 000 |
| 00384620000115 | K043148 | 000 |
| 00384620000122 | K043148 | 000 |
| 00384620000139 | K043148 | 000 |
| 00384620000146 | K043148 | 000 |
| 00384620000153 | K043148 | 000 |
| 00384620000009 | K043148 | 000 |