The following data is part of a premarket notification filed by Rudolf Riester Gmbh & Co. Kg with the FDA for Schiotz Tonometer Spec. 5 Straight, Inclined, 3inclined Scale.
Device ID | K945541 |
510k Number | K945541 |
Device Name: | SCHIOTZ TONOMETER SPEC. 5 STRAIGHT, INCLINED, 3INCLINED SCALE |
Classification | Tonometer, Manual |
Applicant | RUDOLF RIESTER GMBH & CO. KG POSTFACH 35 BRUCKSTRABE 31 D-72417 Jungingen, DE |
Contact | Karlheinz Riesr P Resident |
Correspondent | Karlheinz Riesr P Resident RUDOLF RIESTER GMBH & CO. KG POSTFACH 35 BRUCKSTRABE 31 D-72417 Jungingen, DE |
Product Code | HKY |
CFR Regulation Number | 886.1930 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-11-10 |
Decision Date | 1995-05-08 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00190660156084 | K945541 | 000 |
B091131070 | K945541 | 000 |
B091131100 | K945541 | 000 |
00841668112168 | K945541 | 000 |
00190660156022 | K945541 | 000 |
00190660156039 | K945541 | 000 |
00190660156046 | K945541 | 000 |
00190660156053 | K945541 | 000 |
00190660156060 | K945541 | 000 |
00190660156077 | K945541 | 000 |
H834181321 | K945541 | 000 |