The following data is part of a premarket notification filed by Swemed Laboratories, Inc. with the FDA for Needle Guide (for Ultrasound Transducers).
| Device ID | K862364 |
| 510k Number | K862364 |
| Device Name: | NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS) |
| Classification | Imager, Ultrasonic Obstetric-gynecologic |
| Applicant | SWEMED LABORATORIES, INC. FULLRIGGAREGATAN 12 B S-421 74 V.FROLUNDA Sweden, SE |
| Contact | Goran Itskowitz |
| Correspondent | Goran Itskowitz SWEMED LABORATORIES, INC. FULLRIGGAREGATAN 12 B S-421 74 V.FROLUNDA Sweden, SE |
| Product Code | HEM |
| CFR Regulation Number | 884.2225 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-24 |
| Decision Date | 1986-08-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17350025911677 | K862364 | 000 |
| 17350025911653 | K862364 | 000 |
| 17350025911646 | K862364 | 000 |