The following data is part of a premarket notification filed by Rand S.r.l. with the FDA for Performer Ht/ Hang&go Ht Basic.
Device ID | K120026 |
510k Number | K120026 |
Device Name: | PERFORMER HT/ HANG&GO HT BASIC |
Classification | Warmer, Thermal, Infusion Fluid |
Applicant | RAND S.R.L. VIA STATALE 12,62 Medolla, (mo), IT 41036 |
Contact | Simone Ceretti |
Correspondent | Simone Ceretti RAND S.R.L. VIA STATALE 12,62 Medolla, (mo), IT 41036 |
Product Code | LGZ |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-01-03 |
Decision Date | 2012-05-08 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
M640R99000900001 | K120026 | 000 |
M640R51000710031 | K120026 | 000 |
M640R51000710001 | K120026 | 000 |
M640R51000710041 | K120026 | 000 |
M640R99000900011 | K120026 | 000 |
M640R99000900021 | K120026 | 000 |