The following data is part of a premarket notification filed by Karmel Medical Acoustic Technologies Ltd. with the FDA for Pulmotrack,model 1010.
| Device ID | K980878 |
| 510k Number | K980878 |
| Device Name: | PULMOTRACK,MODEL 1010 |
| Classification | Calculator, Pulmonary Function Interpretor (diagnostic) |
| Applicant | KARMEL MEDICAL ACOUSTIC TECHNOLOGIES LTD. 9 EZEL STREET, PO BOX 389 Tirat Hacarmel, IL 39554 |
| Contact | Charles S Irving |
| Correspondent | Charles S Irving KARMEL MEDICAL ACOUSTIC TECHNOLOGIES LTD. 9 EZEL STREET, PO BOX 389 Tirat Hacarmel, IL 39554 |
| Product Code | BZM |
| CFR Regulation Number | 868.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-09 |
| Decision Date | 1998-12-28 |
| Summary: | summary |