The following data is part of a premarket notification filed by Spirometrics Medical Equipment Co. with the FDA for Pc Flow +.
| Device ID | K001528 |
| 510k Number | K001528 |
| Device Name: | PC FLOW + |
| Classification | Spirometer, Diagnostic |
| Applicant | SPIROMETRICS MEDICAL EQUIPMENT CO. 49 PLAIN ST. N. Attleboro, MA 02760 -4153 |
| Contact | James R Veale |
| Correspondent | James R Veale SPIROMETRICS MEDICAL EQUIPMENT CO. 49 PLAIN ST. N. Attleboro, MA 02760 -4153 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-17 |
| Decision Date | 2001-01-18 |