The following data is part of a premarket notification filed by Ndd Medical Technologies with the FDA for Ndd Medical Technologies Easyone Spirometer: Frontline Model 2000 And Diagnostic Model 2001.
| Device ID | K993921 |
| 510k Number | K993921 |
| Device Name: | NDD MEDICAL TECHNOLOGIES EASYONE SPIROMETER: FRONTLINE MODEL 2000 AND DIAGNOSTIC MODEL 2001 |
| Classification | Spirometer, Diagnostic |
| Applicant | NDD MEDICAL TECHNOLOGIES 17 PROGRESS ANENUE Chelmsford, MA 01824 |
| Contact | Oscar Kaelin |
| Correspondent | Oscar Kaelin NDD MEDICAL TECHNOLOGIES 17 PROGRESS ANENUE Chelmsford, MA 01824 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-18 |
| Decision Date | 2000-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640142190059 | K993921 | 000 |
| 07640142190042 | K993921 | 000 |
| 20612479194414 | K993921 | 000 |
| 20612479194407 | K993921 | 000 |
| 20612479194391 | K993921 | 000 |
| 20612479194384 | K993921 | 000 |