The following data is part of a premarket notification filed by Pari Respiratory Equipment, Inc. with the FDA for Erapid Nebulizer System.
| Device ID | K112859 |
| 510k Number | K112859 |
| Device Name: | ERAPID NEBULIZER SYSTEM |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | PARI RESPIRATORY EQUIPMENT, INC. 2943 OAKLAKE BLVD. Midlothian, VA 23112 |
| Contact | James L Mcintire |
| Correspondent | James L Mcintire PARI RESPIRATORY EQUIPMENT, INC. 2943 OAKLAKE BLVD. Midlothian, VA 23112 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-30 |
| Decision Date | 2012-05-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00744229780168 | K112859 | 000 |
| 00744229789055 | K112859 | 000 |
| 00744229780052 | K112859 | 000 |
| 00744229678175 | K112859 | 000 |
| 00744229178071 | K112859 | 000 |
| 00744229178088 | K112859 | 000 |