The following data is part of a premarket notification filed by Life Sciences Manufacturing, Inc. with the FDA for Pag Microprocessor-controlled Module.
| Device ID | K900365 |
| 510k Number | K900365 |
| Device Name: | PAG MICROPROCESSOR-CONTROLLED MODULE |
| Classification | Phonocardiograph |
| Applicant | LIFE SCIENCES MANUFACTURING, INC. AIRPORT INDUSTRIAL PARK BOX 37F West Lebanon, NH 03784 |
| Contact | Robert S Cutler |
| Correspondent | Robert S Cutler LIFE SCIENCES MANUFACTURING, INC. AIRPORT INDUSTRIAL PARK BOX 37F West Lebanon, NH 03784 |
| Product Code | DQC |
| CFR Regulation Number | 870.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-25 |
| Decision Date | 1990-07-18 |