The following data is part of a premarket notification filed by Rud Riester Gmbh & Co Kg with the FDA for Minimus I; Minimus Iii, Sanaphon.
Device ID | K942649 |
510k Number | K942649 |
Device Name: | MINIMUS I; MINIMUS III, SANAPHON |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | RUD RIESTER GMBH & CO KG BRUCKSTR.31,P.O.BOX 35 Jungingen, DE |
Contact | Karlheinz Riester |
Correspondent | Karlheinz Riester RUD RIESTER GMBH & CO KG BRUCKSTR.31,P.O.BOX 35 Jungingen, DE |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-05-31 |
Decision Date | 1994-11-29 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04045396102507 | K942649 | 000 |