NEBULIZER HEATER
FDA 510(k) clearance K882935 · decided 1988-12-27
Clearance details
- K-number
- K882935
- Device name
- NEBULIZER HEATER
- Applicant
- Automatic Liquid Packaging, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-07-13
- Decision date
- 1988-12-27
- Days to decision
- 167 days
- Clearance type
- Traditional
- Product code
- CAF
- Device class
- 2
- Regulation number
- 868.5630
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Woodstock, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| STERILE SALINE PRESERVED SOLUTION (P850070/S010) | Automatic Liquid Packaging, Inc. | 1997-07-02 |
| STERILE SALINE PRESERVED SOLUTION (P850070/S009) | Automatic Liquid Packaging, Inc. | 1997-06-20 |
| STERILE SALINE PRESERVED SOLUTION (P850070/S008) | Automatic Liquid Packaging, Inc. | 1996-07-10 |
| STERILE UNPRESERVED SALINE SOLUTION (P850070/S006) | Automatic Liquid Packaging, Inc. | 1990-11-05 |
| STERILE UNPRESERVED SALINE SOLUTION (P850070/S005) | Automatic Liquid Packaging, Inc. | 1990-06-22 |
| 4 OZ. STERILE UNPRESERVED SALINE SOLUTION (P850070/S004) | Automatic Liquid Packaging, Inc. | 1990-03-15 |
| STERICON SALINE SOLUTION (P850070/S003) | Automatic Liquid Packaging, Inc. | 1989-09-18 |
| STERICON SALINE SOLUTION (P850070/S002) | Automatic Liquid Packaging, Inc. | 1987-12-29 |