The following data is part of a premarket notification filed by Stihler Electronic Gmbh with the FDA for Prismatherm Ii, Astoline.
| Device ID | K991159 |
| 510k Number | K991159 |
| Device Name: | PRISMATHERM II, ASTOLINE |
| Classification | Warmer, Blood, Non-electromagnetic Radiation |
| Applicant | STIHLER ELECTRONIC GMBH 30 NORTHPORT RD. Sound Beach, NY 11789 -1734 |
| Contact | Richard C Lanzillotto |
| Correspondent | Richard C Lanzillotto STIHLER ELECTRONIC GMBH 30 NORTHPORT RD. Sound Beach, NY 11789 -1734 |
| Product Code | BSB |
| CFR Regulation Number | 864.9205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-07 |
| Decision Date | 1999-09-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260114149910 | K991159 | 000 |