The following data is part of a premarket notification filed by Jeneric/pentron, Inc. with the FDA for Ap-18.
| Device ID | K953642 |
| 510k Number | K953642 |
| Device Name: | AP-18 |
| Classification | Plethysmograph, Volume |
| Applicant | JENERIC/PENTRON, INC. 125 N. PLAINS IND. RD. Wallingford, CT 06492 -0724 |
| Contact | Joseph Macdougald |
| Correspondent | Joseph Macdougald JENERIC/PENTRON, INC. 125 N. PLAINS IND. RD. Wallingford, CT 06492 -0724 |
| Product Code | JEH |
| CFR Regulation Number | 868.1760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-04 |
| Decision Date | 1995-12-12 |