The following data is part of a premarket notification filed by Robert Bosch Corp. with the FDA for Hv-4.
Device ID | K853154 |
510k Number | K853154 |
Device Name: | HV-4 |
Classification | Stimulator, Muscle, Powered |
Applicant | ROBERT BOSCH CORP. FLOWER FIELD BLDG. #17 MILL POND ROAD St. James, NY 11780 |
Contact | Andrew Schaeffer |
Correspondent | Andrew Schaeffer ROBERT BOSCH CORP. FLOWER FIELD BLDG. #17 MILL POND ROAD St. James, NY 11780 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-07-29 |
Decision Date | 1986-03-28 |