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 |