HR UNIT
FDA 510(k) clearance K782148 · decided 1979-01-08
Clearance details
- K-number
- K782148
- Device name
- HR UNIT
- Applicant
- Parke-Davis Co.
- Decision
- Substantially Equivalent
- Date received
- 1978-12-22
- Decision date
- 1979-01-08
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- IQP
- Device class
- 1
- Regulation number
- 890.3025
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- 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.