The following data is part of a premarket notification filed by Hill-med, Inc. with the FDA for Hm-spiro.
| Device ID | K951718 |
| 510k Number | K951718 |
| Device Name: | HM-SPIRO |
| Classification | Spirometer, Diagnostic |
| Applicant | HILL-MED, INC. C/O REGULATORY/MARKET SERVICE P.O. BOX 2010 Palm Harbor, FL 34682 |
| Contact | Ernesto Ackerman |
| Correspondent | Ernesto Ackerman HILL-MED, INC. C/O REGULATORY/MARKET SERVICE P.O. BOX 2010 Palm Harbor, FL 34682 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-13 |
| Decision Date | 1995-12-20 |