The following data is part of a premarket notification filed by Stihler Electronic Gmbh with the FDA for Astotherm Plus, Astotubes, Astoline.
| Device ID | K991160 |
| 510k Number | K991160 |
| Device Name: | ASTOTHERM PLUS, ASTOTUBES, 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 | 1999-09-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260114140955 | K991160 | 000 |
| 04260114140382 | K991160 | 000 |
| 04260114140399 | K991160 | 000 |
| 04260114140405 | K991160 | 000 |
| 04260114140443 | K991160 | 000 |
| 04260114140450 | K991160 | 000 |
| 04260114140467 | K991160 | 000 |
| 04260114140474 | K991160 | 000 |
| 04260114140481 | K991160 | 000 |
| 04260114140528 | K991160 | 000 |
| 04260114140016 | K991160 | 000 |
| 04260114140412 | K991160 | 000 |
| 04260114140429 | K991160 | 000 |
| 04260114140436 | K991160 | 000 |
| 04260114140900 | K991160 | 000 |
| 04260114140917 | K991160 | 000 |
| 04260114140924 | K991160 | 000 |
| 04260114140931 | K991160 | 000 |
| 04260114140375 | K991160 | 000 |