The following data is part of a premarket notification filed by Plane Iii, Inc. with the FDA for Pediatric Airway Measurement System & P.a.m.s..
Device ID | K880441 |
510k Number | K880441 |
Device Name: | PEDIATRIC AIRWAY MEASUREMENT SYSTEM & P.A.M.S. |
Classification | Tape, Measuring, Rulers And Calipers |
Applicant | PLANE III, INC. P.O. BOX 940 Lebanon, NH 03766 |
Contact | Allen J Hinkle |
Correspondent | Allen J Hinkle PLANE III, INC. P.O. BOX 940 Lebanon, NH 03766 |
Product Code | FTY |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-02-02 |
Decision Date | 1988-02-18 |