The following data is part of a premarket notification filed by Steris Corporation with the FDA for Amsco Warming Cabinet.
Device ID | K092823 |
510k Number | K092823 |
Device Name: | AMSCO WARMING CABINET |
Classification | Warmer, Thermal, Infusion Fluid |
Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
Contact | Robert F Sullivan |
Correspondent | Robert F Sullivan STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
Product Code | LGZ |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-09-14 |
Decision Date | 2009-12-18 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00724995154196 | K092823 | 000 |
00724995154035 | K092823 | 000 |
00724995154028 | K092823 | 000 |
00724995154011 | K092823 | 000 |
00724995154004 | K092823 | 000 |
00724995153991 | K092823 | 000 |
00724995153984 | K092823 | 000 |
00724995153977 | K092823 | 000 |
00724995153960 | K092823 | 000 |
00724995153953 | K092823 | 000 |
00724995153946 | K092823 | 000 |
00724995154042 | K092823 | 000 |
00724995154059 | K092823 | 000 |
00724995154158 | K092823 | 000 |
00724995154141 | K092823 | 000 |
00724995154134 | K092823 | 000 |
00724995154127 | K092823 | 000 |
00724995154110 | K092823 | 000 |
00724995154103 | K092823 | 000 |
00724995154097 | K092823 | 000 |
00724995154080 | K092823 | 000 |
00724995154073 | K092823 | 000 |
00724995154066 | K092823 | 000 |
00724995153939 | K092823 | 000 |