The following data is part of a premarket notification filed by Timeter Instrument Corp. with the FDA for L.a.p. Spirometer.
| Device ID | K864836 |
| 510k Number | K864836 |
| Device Name: | L.A.P. SPIROMETER |
| Classification | Calculator, Predicted Values, Pulmonary Function |
| Applicant | TIMETER INSTRUMENT CORP. 2501 OREGON PIKE Lancaster, PA 17601 |
| Contact | Terry L Landis |
| Correspondent | Terry L Landis TIMETER INSTRUMENT CORP. 2501 OREGON PIKE Lancaster, PA 17601 |
| Product Code | BTY |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-09 |
| Decision Date | 1987-03-06 |