The following data is part of a premarket notification filed by Spirometrics, Inc. with the FDA for Spirometrics Model 2500 Flowmate(tm).
| Device ID | K863953 |
| 510k Number | K863953 |
| Device Name: | SPIROMETRICS MODEL 2500 FLOWMATE(TM) |
| Classification | Calculator, Pulmonary Function Interpretor (diagnostic) |
| Applicant | SPIROMETRICS, INC. SUITE 1203 CRYSTAL PLAZA BLDG1 2001 JEFFERSON DAVIS, BOX 2286 Arlington, VA 22202 |
| Contact | Jerry Berkstresser |
| Correspondent | Jerry Berkstresser SPIROMETRICS, INC. SUITE 1203 CRYSTAL PLAZA BLDG1 2001 JEFFERSON DAVIS, BOX 2286 Arlington, VA 22202 |
| Product Code | BZM |
| CFR Regulation Number | 868.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-10 |
| Decision Date | 1987-01-15 |