The following data is part of a premarket notification filed by Arjo, Inc. with the FDA for Recumbent Bathing Systems, Rhapsody And Primo.
Device ID | K001079 |
510k Number | K001079 |
Device Name: | RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO |
Classification | Bath, Hydro-massage |
Applicant | ARJO, INC. 50 NORTH GARY AVE., SUITE A Roselle, IL 60172 -1684 |
Contact | David Insco |
Correspondent | David Insco ARJO, INC. 50 NORTH GARY AVE., SUITE A Roselle, IL 60172 -1684 |
Product Code | ILJ |
CFR Regulation Number | 890.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-04-04 |
Decision Date | 2000-05-01 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05055982728560 | K001079 | 000 |