The following data is part of a premarket notification filed by Instromedix, Inc. with the FDA for Modified External Pad.
| Device ID | K891000 |
| 510k Number | K891000 |
| Device Name: | MODIFIED EXTERNAL PAD |
| Classification | Instruments, Surgical, Cardiovascular |
| Applicant | INSTROMEDIX, INC. ONE TECHNOLOGY CENTER 7431 N.E. EVERGREEN PARKWAY Hillsboro, OR 97124 -5898 |
| Contact | Semler, M.d. |
| Correspondent | Semler, M.d. INSTROMEDIX, INC. ONE TECHNOLOGY CENTER 7431 N.E. EVERGREEN PARKWAY Hillsboro, OR 97124 -5898 |
| Product Code | DWS |
| CFR Regulation Number | 870.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-27 |
| Decision Date | 1989-05-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10815614020200 | K891000 | 000 |
| 10815614020217 | K891000 | 000 |
| 10815614020194 | K891000 | 000 |