The following data is part of a premarket notification filed by Aquarius Electronics, Inc. with the FDA for Aquahab, Model 120-72-101.
Device ID | K945733 |
510k Number | K945733 |
Device Name: | AQUAHAB, MODEL 120-72-101 |
Classification | Exerciser, Powered |
Applicant | AQUARIUS ELECTRONICS, INC. 6501 LINGLESTOWN RD. Harrisburg, PA 17112 -1316 |
Contact | Raymon O Walmer, Jr |
Correspondent | Raymon O Walmer, Jr AQUARIUS ELECTRONICS, INC. 6501 LINGLESTOWN RD. Harrisburg, PA 17112 -1316 |
Product Code | BXB |
CFR Regulation Number | 890.5380 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-11-23 |
Decision Date | 1995-09-15 |