The following data is part of a premarket notification filed by Advanced Technology Laboratories, Inc. with the FDA for Scanhead 2.25mhz Added To Ultramark 4.
Device ID | K843130 |
510k Number | K843130 |
Device Name: | SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 4 |
Classification | Transducer, Ultrasonic |
Applicant | ADVANCED TECHNOLOGY LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Contact | Francis G Smith |
Correspondent | Francis G Smith ADVANCED TECHNOLOGY LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JOP |
CFR Regulation Number | 870.2880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-08-09 |
Decision Date | 1984-12-06 |