The following data is part of a premarket notification filed by Cheetah Medical Inc. with the FDA for Cheetah Nicom System.
| Device ID | K101487 |
| 510k Number | K101487 |
| Device Name: | CHEETAH NICOM SYSTEM |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | CHEETAH MEDICAL INC. 12154 DARNESTOWN RD. #236 Gaithersburg, MD 20878 |
| Contact | Rhona Shanker |
| Correspondent | Rhona Shanker CHEETAH MEDICAL INC. 12154 DARNESTOWN RD. #236 Gaithersburg, MD 20878 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-28 |
| Decision Date | 2010-07-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 77290013030046 | K101487 | 000 |
| 07290013030047 | K101487 | 000 |