The following data is part of a premarket notification filed by Morgan Scientific, Inc. with the FDA for Spiro'air.
| Device ID | K042595 |
| 510k Number | K042595 |
| Device Name: | SPIRO'AIR |
| Classification | Spirometer, Diagnostic |
| Applicant | MORGAN SCIENTIFIC, INC. 151 ESSEX ST. Haverhill, MA 01832 |
| Contact | Patrick Morgan |
| Correspondent | Patrick Morgan MORGAN SCIENTIFIC, INC. 151 ESSEX ST. Haverhill, MA 01832 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-23 |
| Decision Date | 2005-05-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05407003163018 | K042595 | 000 |