The following data is part of a premarket notification filed by Suntech Medical Instruments, Inc. with the FDA for Oscar 2, Model 222.
| Device ID | K003004 |
| 510k Number | K003004 |
| Device Name: | OSCAR 2, MODEL 222 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | SUNTECH MEDICAL INSTRUMENTS, INC. 377 ROUTE 17 Hasbrouck, NJ 07460 |
| Contact | George Myers |
| Correspondent | George Myers SUNTECH MEDICAL INSTRUMENTS, INC. 377 ROUTE 17 Hasbrouck, NJ 07460 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-25 |
| Decision Date | 2000-10-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04045396915091 | K003004 | 000 |
| 10840935101130 | K003004 | 000 |
| 10840935101123 | K003004 | 000 |
| 10840935101116 | K003004 | 000 |
| 10840935101109 | K003004 | 000 |
| 10840935101093 | K003004 | 000 |
| 10840935101086 | K003004 | 000 |
| 10840935101079 | K003004 | 000 |
| 10840935101062 | K003004 | 000 |
| 10840935101055 | K003004 | 000 |
| 10840935101048 | K003004 | 000 |
| 10840935101031 | K003004 | 000 |
| 10840935109600 | K003004 | 000 |
| 10840935109648 | K003004 | 000 |
| 10840935101147 | K003004 | 000 |
| 10840935101154 | K003004 | 000 |
| 10840935107743 | K003004 | 000 |
| 10840935107736 | K003004 | 000 |
| 10840935107729 | K003004 | 000 |
| 10840935107712 | K003004 | 000 |
| 10840935107705 | K003004 | 000 |
| 10840935107675 | K003004 | 000 |
| 10840935106326 | K003004 | 000 |
| 10840935105374 | K003004 | 000 |
| 10840935105367 | K003004 | 000 |
| 10840935105343 | K003004 | 000 |
| 10840935105336 | K003004 | 000 |
| 10840935101178 | K003004 | 000 |
| 10840935101161 | K003004 | 000 |
| 10840935109631 | K003004 | 000 |