FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL T 101 CLINICAL TRANSMITTER
K Number: K842435
·
Decision May 16, 1985
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
296
Applicant Total
5
Review Days
330
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Basic Information
- Device Name
- MODEL T 101 CLINICAL TRANSMITTER
- K Number
- K842435
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2920
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Biometric Products, Inc.
- Date Received
- June 20, 1984
- Decision Date
- May 16, 1985
- Product Code
- DXH
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | FDA class 2 | Cardiovascular |
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Other Clearances by Biometric Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K933021 | MODEL T131 MEMORY TRANSMITTER | Jun 6, 1994 | Substantially Equivalent |
| K863376 | MODEL MC-1 SURGICAL VIDEO CAMERA | Oct 2, 1986 | Substantially Equivalent |
| K840032 | TELEPHONE RECEIVERS R101 R111 | Oct 26, 1984 | Unknown |
| K832951 | MEMORY LOOP TRANSMITTER #121 | Feb 17, 1984 | Substantially Equivalent |