The following data is part of a premarket notification filed by Sdi Diagnostics, Inc. with the FDA for Spirotel, Model 29-1020.
Device ID | K031643 |
510k Number | K031643 |
Device Name: | SPIROTEL, MODEL 29-1020 |
Classification | Spirometer, Diagnostic |
Applicant | SDI DIAGNOSTICS, INC. 10 HAMPDEN DR. Easton, MA 02375 |
Contact | Michael J Boyle |
Correspondent | Michael J Boyle SDI DIAGNOSTICS, INC. 10 HAMPDEN DR. Easton, MA 02375 |
Product Code | BZG |
CFR Regulation Number | 868.1840 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-05-27 |
Decision Date | 2003-12-09 |