The following data is part of a premarket notification filed by Brentwood Medical Technology Corp. with the FDA for Brentwood Iqmark Digital Spirometer (includes Disposable Pneumotach Mouthpieces And 3-liter Calibration Syringe.
| Device ID | K002499 |
| 510k Number | K002499 |
| Device Name: | BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH MOUTHPIECES AND 3-LITER CALIBRATION SYRINGE |
| Classification | Spirometer, Diagnostic |
| Applicant | BRENTWOOD MEDICAL TECHNOLOGY CORP. 3300 FUJITA ST. Torrance, CA 90505 |
| Contact | Glen Mizelle |
| Correspondent | Glen Mizelle BRENTWOOD MEDICAL TECHNOLOGY CORP. 3300 FUJITA ST. Torrance, CA 90505 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-14 |
| Decision Date | 2000-11-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841709107917 | K002499 | 000 |
| 00841709107931 | K002499 | 000 |
| 00841709107924 | K002499 | 000 |