The following data is part of a premarket notification filed by Stihler Electronic Gmbh with the FDA for Astoflo Plus.
| Device ID | K082765 |
| 510k Number | K082765 |
| Device Name: | ASTOFLO PLUS |
| Classification | Warmer, Thermal, Infusion Fluid |
| Applicant | STIHLER ELECTRONIC GMBH 30 NORTHPORT RD. Sound Beach, NY 11789 -1734 |
| Contact | Stephen T Mlcoch |
| Correspondent | Stephen T Mlcoch STIHLER ELECTRONIC GMBH 30 NORTHPORT RD. Sound Beach, NY 11789 -1734 |
| Product Code | LGZ |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-22 |
| Decision Date | 2008-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260114140894 | K082765 | 000 |
| 04260114140603 | K082765 | 000 |
| 04260114140658 | K082765 | 000 |
| 04260114140665 | K082765 | 000 |
| 04260114140672 | K082765 | 000 |
| 04260114140689 | K082765 | 000 |
| 04260114140696 | K082765 | 000 |
| 04260114140702 | K082765 | 000 |
| 04260114140887 | K082765 | 000 |
| 04260114140597 | K082765 | 000 |