The following data is part of a premarket notification filed by Pari Innovative Manufacturers, Inc. with the FDA for Modification To: Eflow Electronic Inhaler/nebulizer.
| Device ID | K072670 |
| 510k Number | K072670 |
| Device Name: | MODIFICATION TO: EFLOW ELECTRONIC INHALER/NEBULIZER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | PARI INNOVATIVE MANUFACTURERS, INC. 2943 OAKLAKE BLVD. Midlothian, VA 23112 |
| Contact | James Mcintire |
| Correspondent | Jay Kogoma INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | Yes |
| Date Received | 2007-09-21 |
| Decision Date | 2007-12-13 |
| Summary: | summary |