NEOTECH MECONIUM ASPIRATOR (STERILE)
FDA 510(k) clearance K880487 · decided 1988-05-06
Clearance details
- K-number
- K880487
- Device name
- NEOTECH MECONIUM ASPIRATOR (STERILE)
- Applicant
- Neotech Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-02-04
- Decision date
- 1988-05-06
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- BTR
- Device class
- 2
- Regulation number
- 868.5730
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Chatsworth, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.