The following data is part of a premarket notification filed by Eco-med Pharmaceuticals, Inc. with the FDA for Ecogel 200 Ultrasound Gel.
Device ID | K955246 |
510k Number | K955246 |
Device Name: | ECOGEL 200 ULTRASOUND GEL |
Classification | Transducer, Ultrasonic, Diagnostic |
Applicant | ECO-MED PHARMACEUTICALS, INC. 6155 TOMKEN ROAD UNIT 13 Mississauga, Ontario, CA L4w 1h3 |
Contact | Paul L Hooey |
Correspondent | Paul L Hooey ECO-MED PHARMACEUTICALS, INC. 6155 TOMKEN ROAD UNIT 13 Mississauga, Ontario, CA L4w 1h3 |
Product Code | ITX |
CFR Regulation Number | 892.1570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-11-15 |
Decision Date | 1996-02-21 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00628055650928 | K955246 | 000 |
00628055650553 | K955246 | 000 |
00628055650492 | K955246 | 000 |
M3684002GF2 | K955246 | 000 |
M3684001GF2 | K955246 | 000 |
00628055650751 | K955246 | 000 |
00850024089822 | K955246 | 000 |
00850024089549 | K955246 | 000 |
00850024089211 | K955246 | 000 |
05060813630394 | K955246 | 000 |
05060813630387 | K955246 | 000 |
05060813630370 | K955246 | 000 |
05060813630363 | K955246 | 000 |
05060813630356 | K955246 | 000 |
05060813630349 | K955246 | 000 |
M220P3011053 | K955246 | 000 |
M220P3010083 | K955246 | 000 |
50885632134355 | K955246 | 000 |
00628055650584 | K955246 | 000 |
00628055650683 | K955246 | 000 |
00628055650706 | K955246 | 000 |
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00628055650447 | K955246 | 000 |
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00628055650423 | K955246 | 000 |
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00858703006269 | K955246 | 000 |
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00812433020001 | K955246 | 000 |
00628055650713 | K955246 | 000 |
00628055650973 | K955246 | 000 |
50885632134348 | K955246 | 000 |