The following data is part of a premarket notification filed by Polytechnic Resources, Inc. with the FDA for Polytech Pulmonary Function Filter.
| Device ID | K042758 |
| 510k Number | K042758 |
| Device Name: | POLYTECH PULMONARY FUNCTION FILTER |
| Classification | Spirometer, Diagnostic |
| Applicant | POLYTECHNIC RESOURCES, INC. 1107 MIDDLE RIVER ROAD SUITE B-1 Baltimore, MD 21220 |
| Contact | Timothy Byrd |
| Correspondent | Timothy Byrd POLYTECHNIC RESOURCES, INC. 1107 MIDDLE RIVER ROAD SUITE B-1 Baltimore, MD 21220 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-04 |
| Decision Date | 2005-08-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
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