Product Code: HHP FDA class 2 21 CFR 884.4900

Table, Obstetrical, Manual (And Accessories)

Obstetrics/Gynecology

The Manual Obstetrical Table (and accessories) is a manually adjustable examination or delivery table specifically designed to support and position patients during obstetric examinations, labor, or delivery procedures. It is classified as FDA Class 2 (moderate risk) within the Obstetrics/Gynecology specialty and is subject to premarket controls. The product code is HHP, regulated under 21 CFR 884.4900. No special risk flags apply.

510(k)s
2
FEI Numbers
1
Registration Numbers
1
Unique Applicants
2
Years Active
14

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Basic Information

Product Code
HHP
Device Class
FDA class 2
Regulation Number
884.4900
Medical Specialty
Obstetrics/Gynecology
Review Panel
OB
Submission Type
4

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 2 510(k) clearances via K numbers.

K Number Device Name
K963505 TENET MLTI-POSITIONING SURGICAL STIRRUP SYSTEM
K822812 YSI MODEL 23L LACTATE ANALYZER

FEI Numbers

This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.