The following data is part of a premarket notification filed by Advanced Instruments, Inc. with the FDA for Intermittent Compression System Model 5000.
| Device ID | K930526 |
| 510k Number | K930526 |
| Device Name: | INTERMITTENT COMPRESSION SYSTEM MODEL 5000 |
| Classification | Sleeve, Limb, Compressible |
| Applicant | ADVANCED INSTRUMENTS, INC. TOW TECHNOLOGY WAY Norwood, MA 02062 |
| Contact | Douglas Guerette |
| Correspondent | Douglas Guerette ADVANCED INSTRUMENTS, INC. TOW TECHNOLOGY WAY Norwood, MA 02062 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-02 |
| Decision Date | 1993-11-18 |