The following data is part of a premarket notification filed by Rnk Products, Inc. with the FDA for Pcp-usb Stethoscope.
Device ID | K132560 |
510k Number | K132560 |
Device Name: | PCP-USB STETHOSCOPE |
Classification | Stethoscope, Electronic |
Applicant | RNK PRODUCTS, INC. 8247 Devereux Dr Ste 101 Melbourne, FL 32940 |
Contact | Charles R Abbruscato |
Correspondent | Charles R Abbruscato RNK PRODUCTS, INC. 8247 Devereux Dr Ste 101 Melbourne, FL 32940 |
Product Code | DQD |
CFR Regulation Number | 870.1875 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-08-15 |
Decision Date | 2013-10-11 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00677994002022 | K132560 | 000 |
00677986002023 | K132560 | 000 |