The following data is part of a premarket notification filed by Nimbic Systems, Inc with the FDA for Air Barrier System (abs).
| Device ID | K123006 |
| 510k Number | K123006 |
| Device Name: | AIR BARRIER SYSTEM (ABS) |
| Classification | Air Filter Portable Apparatus |
| Applicant | NIMBIC SYSTEMS, INC 11874 SOUTH EVELYN CIRCLE Houston, TX 77477 -3404 |
| Contact | Harvey Knauss |
| Correspondent | Harvey Knauss NIMBIC SYSTEMS, INC 11874 SOUTH EVELYN CIRCLE Houston, TX 77477 -3404 |
| Product Code | ORC |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-27 |
| Decision Date | 2013-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00869284000249 | K123006 | 000 |
| 00869284000225 | K123006 | 000 |
| 00869284000232 | K123006 | 000 |
| 00842430115745 | K123006 | 000 |
| 00842430115448 | K123006 | 000 |
| 00842430115455 | K123006 | 000 |