The following data is part of a premarket notification filed by Biometric Products, Inc. with the FDA for Telephone Receivers R101 R111.
Device ID | K840032 |
510k Number | K840032 |
Device Name: | TELEPHONE RECEIVERS R101 R111 |
Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
Applicant | BIOMETRIC PRODUCTS, INC. 4275A SW 73RD AVE. Miami, FL 33155 |
Contact | Katchis, Jr. |
Correspondent | Katchis, Jr. BIOMETRIC PRODUCTS, INC. 4275A SW 73RD AVE. Miami, FL 33155 |
Product Code | DXH |
CFR Regulation Number | 870.2920 [🔎] |
Decision | Se - Postmarket Surveillance Required (SESP) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-01-05 |
Decision Date | 1984-10-26 |