The following data is part of a premarket notification filed by Simtec, Inc. with the FDA for Intelliflow Respiratory Analyzer.
| Device ID | K970840 |
| 510k Number | K970840 |
| Device Name: | INTELLIFLOW RESPIRATORY ANALYZER |
| Classification | Calculator, Pulmonary Function Data |
| Applicant | SIMTEC, INC. 217 NORTH MAIN ST. Marion, SC 29571 |
| Contact | John Simpson |
| Correspondent | John Simpson SIMTEC, INC. 217 NORTH MAIN ST. Marion, SC 29571 |
| Product Code | BZC |
| CFR Regulation Number | 868.1880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-07 |
| Decision Date | 1997-11-26 |