FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THERMOMETER, ELECTRONIC, DIGIMED HOL
K Number: K770777
·
Decision May 3, 1977
Classifications
1
FEI Numbers
488
Registration Numbers
488
Same Product Code
797
Applicant Total
26
Review Days
5
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Basic Information
- Device Name
- THERMOMETER, ELECTRONIC, DIGIMED HOL
- K Number
- K770777
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2910
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Elmed, Inc.
- Date Received
- April 28, 1977
- Decision Date
- May 3, 1977
- Product Code
- FLL
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FLL | Continuous Measurement Thermometer | FDA class 2 | General Hospital |
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Other Clearances by Elmed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K010465 | DENSTAT | May 14, 2001 | Substantially Equivalent |
| K974793 | ELMED ESU 120 M/M DIGITAL | Mar 19, 1998 | Substantially Equivalent |
| K953271 | ELMED RF-ALERT | Jan 18, 1996 | Substantially Equivalent |
| K952110 | ELMED THERMO-FLUX | Aug 14, 1995 | Substantially Equivalent |
| K926517 | ELMED LBC 50-P | Nov 15, 1994 | Substantially Equivalent |
| K932938 | ELMED ESU 300 M/M AND DIGITAL | May 2, 1994 | Substantially Equivalent |
| K921770 | ELECTROSURGICAL UNITS ESU 100L, 100 L M/M & E M/M | May 17, 1993 | Substantially Equivalent |
| K915731 | ELECTROSURGICAL UNITS ESU 30, 70, 70 B, 70 DIGITAL | Nov 5, 1992 | Substantially Equivalent |
| K905417 | ELMED PNEUMOMAT DIGITAL | Jan 31, 1991 | Substantially Equivalent |
| K881431 | SIEMENS STEREODYNATOR 828 | Apr 16, 1990 | Substantially Equivalent |