D.C. AMPLIFIER MODULE
FDA 510(k) clearance K770247 · decided 1977-02-14
Clearance details
- K-number
- K770247
- Device name
- D.C. AMPLIFIER MODULE
- Applicant
- Mennen Greatbatch Electonics
- Decision
- Substantially Equivalent
- Date received
- 1977-02-07
- Decision date
- 1977-02-14
- Days to decision
- 7 days
- Clearance type
- Traditional
- Product code
- DRQ
- Device class
- 2
- Regulation number
- 870.2060
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.