The following data is part of a premarket notification filed by Graseby Andersen with the FDA for Graseby Andersen's, Integrity S700.
| Device ID | K963131 |
| 510k Number | K963131 |
| Device Name: | GRASEBY ANDERSEN'S, INTEGRITY S700 |
| Classification | Spirometer, Diagnostic |
| Applicant | GRASEBY ANDERSEN 500 TECHNOLOGY CT. Smyrna, GA 30082 |
| Contact | Jess Kash |
| Correspondent | Jess Kash GRASEBY ANDERSEN 500 TECHNOLOGY CT. Smyrna, GA 30082 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-12 |
| Decision Date | 1997-02-14 |