The following data is part of a premarket notification filed by Galaxy Aquatics, Inc. with the FDA for Galaxy Md Series Therapypools.
| Device ID | K945824 |
| 510k Number | K945824 |
| Device Name: | GALAXY MD SERIES THERAPYPOOLS |
| Classification | Exerciser, Powered |
| Applicant | GALAXY AQUATICS, INC. 1075 W. SAM HOUSTON PKWY. N. SUITE #210 Houston, TX 77043 -5018 |
| Contact | Klaus P Klosterman |
| Correspondent | Klaus P Klosterman GALAXY AQUATICS, INC. 1075 W. SAM HOUSTON PKWY. N. SUITE #210 Houston, TX 77043 -5018 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-29 |
| Decision Date | 1995-04-05 |