The following data is part of a premarket notification filed by Monaghan Medical Corp. with the FDA for Aerochamber W/mask, Modified.
| Device ID | K930574 |
| 510k Number | K930574 |
| Device Name: | AEROCHAMBER W/MASK, MODIFIED |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | MONAGHAN MEDICAL CORP. FRANKLYN BLDG RT. 9 NORTH P.O. BOX 978 Plattsburgh, NY 12901 |
| Contact | James A Cochie |
| Correspondent | James A Cochie MONAGHAN MEDICAL CORP. FRANKLYN BLDG RT. 9 NORTH P.O. BOX 978 Plattsburgh, NY 12901 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-04 |
| Decision Date | 1994-01-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50604351795506 | K930574 | 000 |
| 00604351795105 | K930574 | 000 |