The following data is part of a premarket notification filed by Bionet Co., Ltd. with the FDA for Spm-300.
| Device ID | K130322 |
| 510k Number | K130322 |
| Device Name: | SPM-300 |
| Classification | Spirometer, Diagnostic |
| Applicant | BIONET CO., LTD. 5405 ALTON PARKWAY, SUITE A530 Irvine, CA 92604 |
| Contact | Marc Goodman |
| Correspondent | Marc Goodman BIONET CO., LTD. 5405 ALTON PARKWAY, SUITE A530 Irvine, CA 92604 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-08 |
| Decision Date | 2013-11-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809276941480 | K130322 | 000 |
| 18809276943726 | K130322 | 000 |