The following data is part of a premarket notification filed by International Biophysics Corporation with the FDA for International Biophysics Corporation Afflovest.
| Device ID | K122480 |
| 510k Number | K122480 |
| Device Name: | INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST |
| Classification | Percussor, Powered-electric |
| Applicant | INTERNATIONAL BIOPHYSICS CORPORATION 2101 E. ST ELMO ROAD SUITE 275 Austin, TX 78744 |
| Contact | H. David Shockley Jr. |
| Correspondent | H. David Shockley Jr. INTERNATIONAL BIOPHYSICS CORPORATION 2101 E. ST ELMO ROAD SUITE 275 Austin, TX 78744 |
| Product Code | BYI |
| CFR Regulation Number | 868.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-14 |
| Decision Date | 2013-03-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814321020087 | K122480 | 000 |
| 00816305023992 | K122480 | 000 |
| 00816305023985 | K122480 | 000 |
| 00816305023749 | K122480 | 000 |
| 00816305023732 | K122480 | 000 |
| 00816305023725 | K122480 | 000 |
| 00816305023718 | K122480 | 000 |
| 00816305024487 | K122480 | 000 |
| 00816305024470 | K122480 | 000 |
| 00816305024463 | K122480 | 000 |
| 00816305024456 | K122480 | 000 |
| 00816305024449 | K122480 | 000 |
| 00816305024432 | K122480 | 000 |
| 00816305024425 | K122480 | 000 |
| 00816305024418 | K122480 | 000 |
| 00816305024500 | K122480 | 000 |
| 00816305024005 | K122480 | 000 |
| 00816305024012 | K122480 | 000 |
| 00816305024029 | K122480 | 000 |
| 00814321020070 | K122480 | 000 |
| 00814321020063 | K122480 | 000 |
| 00814321020056 | K122480 | 000 |
| 00814321020049 | K122480 | 000 |
| 00814321020032 | K122480 | 000 |
| 00814321020025 | K122480 | 000 |
| 00816305024128 | K122480 | 000 |
| 00816305024111 | K122480 | 000 |
| 00816305024104 | K122480 | 000 |
| 00816305024098 | K122480 | 000 |
| 00816305024081 | K122480 | 000 |
| 00816305024074 | K122480 | 000 |
| 00816305024067 | K122480 | 000 |
| 00816305024043 | K122480 | 000 |
| 00816305024036 | K122480 | 000 |
| 00816305024364 | K122480 | 000 |