The following data is part of a premarket notification filed by Curbell Medical Products, Inc. with the FDA for Curbell Branded Patient Monitoring Cables.
Device ID | K182220 |
510k Number | K182220 |
Device Name: | Curbell Branded Patient Monitoring Cables |
Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
Applicant | Curbell Medical Products, Inc. 20 Centre Drive Orchard Park, NY 14127 |
Contact | Michael Winter |
Correspondent | Michael Winter Curbell Medical Products, Inc. 20 Centre Drive Orchard Park, NY 14127 |
Product Code | DSA |
CFR Regulation Number | 870.2900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-08-15 |
Decision Date | 2018-11-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00840828180597 | K182220 | 000 |
10840828184202 | K182220 | 000 |
10840828184196 | K182220 | 000 |
10840828185773 | K182220 | 000 |
10840828186022 | K182220 | 000 |
10840828186015 | K182220 | 000 |
10840828186008 | K182220 | 000 |
10840828185995 | K182220 | 000 |
10840828185988 | K182220 | 000 |
10840828185971 | K182220 | 000 |
10840828190500 | K182220 | 000 |
10840828190494 | K182220 | 000 |
10840828190487 | K182220 | 000 |
10840828190470 | K182220 | 000 |
10840828190463 | K182220 | 000 |
10840828190456 | K182220 | 000 |
10840828190449 | K182220 | 000 |
10840828184219 | K182220 | 000 |
10840828184226 | K182220 | 000 |
10840828184233 | K182220 | 000 |
00840828180580 | K182220 | 000 |
00840828180573 | K182220 | 000 |
00840828180566 | K182220 | 000 |
10840828180556 | K182220 | 000 |
00840828180689 | K182220 | 000 |
00840828180672 | K182220 | 000 |
00840828180665 | K182220 | 000 |
10840828180655 | K182220 | 000 |
00840828180641 | K182220 | 000 |
10840828180631 | K182220 | 000 |
00840828180627 | K182220 | 000 |
10840828180617 | K182220 | 000 |
10840828180600 | K182220 | 000 |
00840828182003 | K182220 | 000 |
10840828184257 | K182220 | 000 |
10840828184240 | K182220 | 000 |
10840828190432 | K182220 | 000 |