The following data is part of a premarket notification filed by Conmed Corp. with the FDA for Ecg Electrode (various).
Device ID | K991105 |
510k Number | K991105 |
Device Name: | ECG ELECTRODE (VARIOUS) |
Classification | Electrode, Electrocardiograph |
Applicant | CONMED CORP. 310 BROAD ST. Utica, NY 13501 -1203 |
Contact | Ira D Duesler |
Correspondent | Ira D Duesler CONMED CORP. 310 BROAD ST. Utica, NY 13501 -1203 |
Product Code | DRX |
CFR Regulation Number | 870.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-04-01 |
Decision Date | 1999-11-26 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10653405003632 | K991105 | 000 |
10653405003380 | K991105 | 000 |
10653405003250 | K991105 | 000 |
10653405003120 | K991105 | 000 |
20653405052941 | K991105 | 000 |
20653405052927 | K991105 | 000 |
20653405004599 | K991105 | 000 |
20653405033728 | K991105 | 000 |
20653405052958 | K991105 | 000 |
20653405052934 | K991105 | 000 |
10653405003489 | K991105 | 000 |
30653405005104 | K991105 | 000 |
10653405003625 | K991105 | 000 |
10653405003618 | K991105 | 000 |
10653405003601 | K991105 | 000 |
30653405005142 | K991105 | 000 |
30653405005135 | K991105 | 000 |
30653405005043 | K991105 | 000 |
30653405005098 | K991105 | 000 |
20653405082559 | K991105 | 000 |
30653405005111 | K991105 | 000 |
20653405003721 | K991105 | 000 |