The following data is part of a premarket notification filed by Exact Medical Manufacturing with the FDA for Emm Ultrasonic Transducer Cover.
| Device ID | K211969 |
| 510k Number | K211969 |
| Device Name: | EMM Ultrasonic Transducer Cover |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | Exact Medical Manufacturing 4917 William Street - Suite C Lancaster, NY 14086 |
| Contact | Ryan Power |
| Correspondent | Abdel B Halim Global Quality And Regulatory Services 10 Scenic Way Monroe, NJ 08831 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-06-24 |
| Decision Date | 2021-08-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850033380385 | K211969 | 000 |
| 26975424192052 | K211969 | 000 |
| 26975424192014 | K211969 | 000 |
| 26975424192007 | K211969 | 000 |
| 16975424191515 | K211969 | 000 |
| 16975424191508 | K211969 | 000 |
| 10680651518351 | K211969 | 000 |
| 10680651518344 | K211969 | 000 |
| 10680651518337 | K211969 | 000 |
| 10680651518276 | K211969 | 000 |
| 16975424193359 | K211969 | 000 |
| 26975424192069 | K211969 | 000 |
| 06975085709374 | K211969 | 000 |
| 16975424191317 | K211969 | 000 |
| 00850033380842 | K211969 | 000 |
| 00850033380989 | K211969 | 000 |
| 00850033380965 | K211969 | 000 |
| 00850033380941 | K211969 | 000 |
| 00850033380927 | K211969 | 000 |
| 00850033380897 | K211969 | 000 |
| 00860003700853 | K211969 | 000 |
| 16975085708817 | K211969 | 000 |
| 26975085708364 | K211969 | 000 |
| 16975424191324 | K211969 | 000 |
| 16975424193342 | K211969 | 000 |