The following data is part of a premarket notification filed by Infrasonics Corp. with the FDA for Modified Star Calc.
| Device ID | K895963 |
| 510k Number | K895963 |
| Device Name: | MODIFIED STAR CALC |
| Classification | Calculator, Pulmonary Function Data |
| Applicant | INFRASONICS CORP. 9944 BARNES CANYON RD. San Diego, CA 92121 |
| Contact | Jim Hitchin |
| Correspondent | Jim Hitchin INFRASONICS CORP. 9944 BARNES CANYON RD. San Diego, CA 92121 |
| Product Code | BZC |
| CFR Regulation Number | 868.1880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-11 |
| Decision Date | 1990-03-16 |