PREGNANCY (W) EDGE
FDA 510(k) clearance K821836 · decided 1982-07-30
Clearance details
- K-number
- K821836
- Device name
- PREGNANCY (W) EDGE
- Applicant
- Body Therapeutics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-06-22
- Decision date
- 1982-07-30
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- QSB
- Device class
- 1
- Regulation number
- 890.3490
- 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.