The following data is part of a premarket notification filed by Huntleigh Technology, Inc. with the FDA for Flowtron Ac200/2.
| Device ID | K874688 |
| 510k Number | K874688 |
| Device Name: | FLOWTRON AC200/2 |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | HUNTLEIGH TECHNOLOGY, INC. 227 ROUTE 33 EAST Manalapan, NJ 07726 |
| Contact | James Britton |
| Correspondent | James Britton HUNTLEIGH TECHNOLOGY, INC. 227 ROUTE 33 EAST Manalapan, NJ 07726 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-13 |
| Decision Date | 1988-09-23 |