The following data is part of a premarket notification filed by Medical Device Inspection Co., Inc. with the FDA for J & J I-330 Series Physiological Monitoring & Biofeedback Instument And Use Software Applications.
| Device ID | K945826 |
| 510k Number | K945826 |
| Device Name: | J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFTWARE APPLICATIONS |
| Classification | Device, Biofeedback |
| Applicant | MEDICAL DEVICE INSPECTION CO., INC. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
| Contact | Anand Akerkar |
| Correspondent | Anand Akerkar MEDICAL DEVICE INSPECTION CO., INC. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-29 |
| Decision Date | 1995-08-04 |