The following data is part of a premarket notification filed by Laytech Medical Co. with the FDA for Peak Flow Rate Meter.
| Device ID | K893827 |
| 510k Number | K893827 |
| Device Name: | PEAK FLOW RATE METER |
| Classification | Device, Urine Flow Rate Measuring, Non-electrical, Disposable |
| Applicant | LAYTECH MEDICAL CO. 816 NICHOLS Arlington Heights, IL 60004 |
| Contact | Catherine S Layton |
| Correspondent | Catherine S Layton LAYTECH MEDICAL CO. 816 NICHOLS Arlington Heights, IL 60004 |
| Product Code | FFG |
| CFR Regulation Number | 876.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-24 |
| Decision Date | 1989-08-11 |