The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Siemens Infinity Eeg Pod.
| Device ID | K991012 |
| 510k Number | K991012 |
| Device Name: | SIEMENS INFINITY EEG POD |
| Classification | Non-normalizing Quantitative Electroencephalograph Software |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 16 ELECTRONICS AVE. Danvers, MA 01923 |
| Contact | Penelope H Greco |
| Correspondent | Penelope H Greco SIEMENS MEDICAL SOLUTIONS USA, INC. 16 ELECTRONICS AVE. Danvers, MA 01923 |
| Product Code | OLT |
| Subsequent Product Code | OMC |
| Subsequent Product Code | ORT |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-26 |
| Decision Date | 1999-06-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04049098053808 | K991012 | 000 |
| 04049098008013 | K991012 | 000 |
| 04049098007887 | K991012 | 000 |